Oral-esophageal-gastric device with esophageal cuff to reduce gastric reflux and/or emesis

ABSTRACT

A nasogastric/orogastric (Ng/Og) airway protection device includes an elongate device body having a distal end for insertion into the stomach through the esophagus and a proximal end. A main lumen extends the length of the device and is configured for at least one of gastric decompression, enteral feeding and enteral medication administration. A sump port is at the distal end. A sump lumen is formed the length of the device body and configured for venting gas and preventing adherence of the device against the gastric wall. An inflatable esophageal cuff is carried by the device body mid-esophagus and an inflation lumen is formed within the device body and connects the inflatable esophageal cuff through which the esophageal cuff is inflated and deflated. Upon inflation of the esophageal cuff, emesis and/or reflux is blocked from passing out of the stomach past the esophageal cuff positioned mid-esophagus to protect a patient&#39;s airway.

RELATED APPLICATION(S)

This application claims priority to U.S. provisional application Ser.Nos. 61/296,304, filed Jan. 19, 2010; 61/311,882, filed Mar. 9, 2010;and 61/356,895, filed Jun. 21, 2010, and is a continuation-in-part ofU.S. patent application Ser. No. 12/643,251 filed Dec. 21, 2009 now U.S.Pat. No. 8,602,987, which claims priority to prior filed U.S.provisional application Ser. No. 61/139,649 filed Dec. 22, 2008, andprior filed U.S. provisional application Ser. No. 61/244,167 filed Sep.21, 2009, and which is a continuation-in-part application of prior filedU.S. application Ser. No. 11/550,125 filed Oct. 17, 2006 now U.S. Pat.No. 8,690,790, which claims priority to U.S. provisional applicationSer. No. 60/727,740 filed Oct. 18, 2005, U.S. provisional applicationSer. No. 60/752,351 filed Dec. 21, 2005, all disclosures which arehereby incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

This invention is directed to the field of medical devices and testingand, more particularly, to apparatus and techniques for evaluatingurinary stress incontinence.

BACKGROUND OF THE INVENTION

According to the American Academy of Family Physicians, urinaryincontinence (UI) affects approximately twelve million persons in theUnited States alone. Although urinary incontinence can occur in both menand women, it is most common in women over the age of 50. There are manycauses of UI, including age related atrophic changes in thegenitourinary anatomy in women after menopause, enlargement of theprostate in men as well as generalized weakening of the pelvic floormuscles, medication side effects, immobility, infection of the urinarytract and various underlying medical co-morbidities including diabetesand hypercalcemia.

There are four basic types of urinary incontinence; functional,overflow, urge and stress. Stress incontinence occurs when there is asudden pressure on the lower abdominal musculature, such as with acough, sneeze, laugh or lifting. Stress incontinence is often secondaryin part to weakening of the pelvic floor musculature, and is commonafter childbirth or abdominal surgery. It has been estimated that stressurinary incontinence occurs at least weekly in one third of adult women.

Additional reports indicate that more than 65% of female incontinencepatients in the United States or 8.3 million women experience stressurinary incontinence. Of these women, approximately 85% or 7 millionhave incontinence primarily due to hypermobility of the bladder outlet,and approximately 15% or 1.3 million have incontinence primarily due toan intrinsic sphincter deficiency. Regardless of the etiology of UI, forthe affected person it maybe a source of significant embarrassment andsocial isolation. As a result of this social stigma, many patients arereluctant to address this issue with their physician. Most primary carephysicians “screen” for urinary incontinence by verbal or writtenquestioning of the patient only. Additional basic evaluation may includea voluntary cough stress test, voiding diary, post void residual urinaryvolume, and urinalysis.

A patient experiencing urinary incontinence must be properly diagnosedto identify the specific type of incontinence from which the patientsuffers. The treatments may be different, depending on the type ofincontinence. Therefore, proper diagnosis becomes important at least forthat reason.

Stress incontinence may result primarily in older women due to loss ofextrinsic support for the pelvic organs and for the neck of the bladder.The tissues of the pelvis and of the distal urethra contain estrogen andprogesterone receptors. Following menopause and decrease of thehormones, the tissues of the urethra may lose resiliency and becomesomewhat flaccid. Under those conditions, any increase inintra-abdominal pressure causes urine in the bladder to be pushedoutwardly as resistance in the urethra is overcome, resulting in leakageof urine. This condition is known as stress incontinence and occurs inthe absence of contractions by the detrusor muscle of the bladder.Stress incontinence may be responsive to treatment with exogenousestrogens, although this is not an effective treatment for all patients,particularly depending on age. Alternative treatments may include pelvicmuscle exercises, α-adrenergic agents, such as phenylpropanolamine, thatact on the α-adrenergic receptors along the urethra and increaseurethral tone.

The most common cause of urinary incontinence, however, is detrusorhyperreflexia, or hyperactivity of the detrusor muscle. This type ofincontinence is believed to result from lack of inhibition of thedetrusor muscle due to a decreased detrusor reflex in the brain stem.Nevertheless, in most affected elderly there appears to be no underlyingneurological defect. In this condition, treatment may includeantispasmodic agents which tend to relax the wall of the bladder.

A typical test employed to distinguish these two types of urinaryincontinence is one which increases intra-abdominal pressure so as to,in turn, put pressure on the bladder. The Valsalva maneuver is one suchtest. In this technique, the patient generates a muscular contraction ofthe chest, abdomen and diaphragm in a forced expiration against a closedglottis. This increases pressure within the thoracic cavity and also inthe abdominal cavity. The Valsalva maneuver also refers to raising thepressure in the nasopharynx by a forced expiration with the mouth closedand the nostrils pinched, for example, to clear the patency of theEustachian tubes. Other testing techniques involve having the patientjump up and down to jostle the bladder, or bend down so as to compressthe abdomen. Yet another method involves having the patient generate oneor more strong voluntary coughs.

It is known, however, that some patients are unable to perform thesephysical acts. For example, a patient may not be able to jump, or tobend, or to generate a strong voluntary cough. Additionally, there aresome patients who will not be correctly diagnosed on the basis of thecough test, perhaps because their coughs are insufficiently strong.Accordingly, there is a need for alternative or supplementary tests thatwill aid in diagnosing urinary stress incontinence.

A rather complete discussion of methods of evaluating urinaryincontinence is found in a February 2006 article by J L Martin et al.entitled, “Systematic Review and Evaluation of Methods of AssessingUrinary Incontinence (hereinafter referred to as Systematic review).”

One of the problems associated with the prior art techniques is thatsome patients are unable or are unwilling to perform the physical actsto the extent needed. For example, a patient may not be able to jump, orto bend, or to generate a strong voluntary cough. For some patients,they maybe able to perform these acts, but be unwilling to do so becausean involuntary release of urine may be embarrassing or contrary to whatis considered proper in society.

SUMMARY OF THE INVENTION

A nasogastric/orogastric (Ng/Og) airway protection device includes anelongate device body having a distal end for insertion into the stomachthrough the esophagus and a proximal end. A main lumen extends thelength of the device and is configured for at least one of gastricdecompression, enteral feeding and enteral medication administration. Asump port is at the distal end. A sump lumen is formed the length of thedevice body and configured for venting gas and preventing adherence ofthe device against the gastric wall. An inflatable esophageal cuff iscarried by the device body mid-esophagus and an inflation lumen isformed within the device body and connects the inflatable esophagealcuff through which the esophageal cuff is inflated and deflated. Uponinflation of the esophageal cuff, emesis and/or reflux is blocked frompassing out of the stomach past the esophageal cuff positionedmid-esophagus to protect a patient's airway.

In one example, a nebulizer lumen extends along the device body andcomprises a port through which medication is delivered foradministrating an involuntary reflex cough test. The esophageal cuffprotects the airway during the involuntary reflex cough test. Anebulizer venturi connects the nebulizer lumen and is configured todeliver nebulized medication around the device body.

In another example, at least one pressure sensor is located on thedevice body and configured to measure pressure in at least one of theupper esophagus, lower esophagus, and stomach. The at least one pressuresensor includes a pressure transducer and a transducer lead connectingthe pressure transducer and extending into the sump lumen. At least onepH sensor is carried by device body in another example and theesophageal cuff is radio-opaque to aid in placement of the esophagealcuff at a predetermined location within the esophagus.

In yet another example, a suction lumen is formed within the device bodyand suction ports communicate with the suction lumen and are configuredto permit suction from the esophagus above the lower esophagealsphincter (LES). The suction ports in one example are configured asone-way valves to permit suction for emesis and/or reflux into thesuction lumen when a vacuum is drawn therethrough. An inflation balloonconnects the inflation lumen at the proximal end of the device body andis configured to permit manual inflation of the esophageal cuff. Amanometer is connected at said inflation lumen at the proximal end tocheck pressure of the esophageal cuff.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, features and advantages of the present invention willbecome apparent from the detailed description of the invention whichfollows, when considered in light of the accompanying drawings in which:

FIG. 1 shows a flowchart of a technique for evaluating a patient forurinary stress incontinence in accordance with one aspect of theinvention.

FIG. 2 shows a flowchart of a technique for conducting a reflexive coughtest (RCT).

FIG. 3 shows a catheter that can be used for carrying out variousaspects of the invention.

FIG. 4 is an illustration of a handheld device that can be used to carryout the invention.

FIG. 5 is a block diagram of an exemplary processing device, such asused in the handheld device, which can be used to carry out aspects ofthe invention.

FIG. 6 is a flowchart of software used to program a processing device inaccordance with one aspect of the invention.

FIGS. 7A and 7B illustrate test results comparing a voluntary cough testand involuntary cough reflex test for assessing stress urinaryincontinence.

FIG. 8 is a block diagram similar to the block diagram shown in FIG. 5and showing a wireless interface and a wireless module in the handhelddevice that communicates wirelessly to a wireless sensing device, whichconnects to catheters or other inputs, including an EMG signal input inaccordance with a non-limiting example.

FIGS. 9 and 10 are graphs of urodynamic tracings showing results for theEMG, detrusor, abdominal and vesicular pressures for the involuntarycough reflex test (iRct) when the EMG is taken from the perineal (FIG.9) and when the EMG is taken from the L5/S1 (FIG. 10) in accordance witha non-limiting example.

FIGS. 11-13 are tables of results and showing statistics, correlationand samples for the average intraabdominal pressure (AIAP) (FIG. 11),the peak intraabdominal pressure (PIAP) (FIG. 12), and the Area underCurve (AUC) (FIG. 13) and comparing the involuntary reflex cough test(RCT) and the voluntary cough test (VCT).

FIGS. 14-16 are graphs showing urodynamic tracings similar to thoseshown in FIGS. 9 and 10, for a patient with a tracheal tube removed andshowing the results for the voluntary cough test (FIGS. 14 and 15) andthe involuntary reflex cough test (FIG. 16).

FIGS. 17A-17C are tables showing a summary of the sensitivity,specificity, PPV and NPV in a study of urodynamic testing for SUI withcomparisons for the voluntary cough test and the involuntary reflexcough test.

FIGS. 18 and 19 are graphs for urodynamic tests similar to those shownin FIGS. 9 and 10 and 14-16 and showing results for a recumbent patientand a voluntary cough test (FIG. 18) and an involuntary reflex coughtest (FIG. 19).

FIG. 20 is a table of results showing a (2×2) chi-squared statisticalanalysis for a series of tests and comparing the involuntary reflexcough test and voluntary cough test.

FIG. 21 are graphs showing urodynamic tracings for a voluntary coughtest and the involuntary reflex cough test in a female patient who doesnot have a history of SUI and showing a summary of results.

FIG. 22 are graphs showing urodynamic tracings for a voluntary coughtest and the involuntary reflex cough test in a female patient who has amoderate/severe history of SUI and showing a summary of results.

FIGS. 23 and 24 are flowcharts showing an example of a method forprocessing data obtained during the involuntary reflex cough test for apatient in an outpatient setting.

FIGS. 25 and 26 are flowcharts showing examples of a method forprocessing data obtained during the involuntary reflex cough test for apatient in an inpatient setting.

FIG. 27 is a block diagram showing various components that can be usedin an embodiment of the handheld device such as described beforerelative to FIG. 5.

FIGS. 28A-28D are respective top, front elevation and side elevationviews for the case or housing that can be used for the handheld devicein accordance with a non-limiting example.

FIG. 29 is a top plan view of a housing cover of the handheld device inaccordance with a non-limiting example.

FIG. 30 is a schematic circuit diagram of a representative example ofthe pressure converter circuit as shown in FIG. 27 that can be used inaccordance with a non-limiting example.

FIG. 31 is a simplified plan view of a catheter that can be used for theurodynamic and medical diagnostic testing in accordance with anon-limiting example.

FIG. 32 is another simplified plain view of another example of acatheter similar to that shown in FIG. 31 that can be used for theurodynamic and medical diagnostic testing in accordance with anon-limiting example.

FIG. 33 is an example of a urinary incontinence pad that can be usedwith a urodynamic catheter and showing pad areas that indicate colorchange for leakage.

FIGS. 34 and 35 are fragmental drawing views showing examples of kitsthat can be used in accordance with a non-limiting example.

FIGS. 36-38 are a top level functional diagram for the operation of thehandheld device in which the analysis algorithm of FIGS. 23-26 areillustrated as a block on FIG. 37.

FIG. 39 is a block diagram showing various components that can be usedin an embodiment of the handheld device, but showing the four channelsystem with two pressure inputs, an EMG input, and a pH input, similarto that shown in FIG. 27.

FIG. 40 is a schematic circuit diagram of a representative example of afour-channel circuit similar to that shown in FIG. 30.

FIGS. 41 and 42 show respective six-channel systems, including aschematic circuit diagram in FIG. 41 and the block diagram in FIG. 40for a six-channel system.

FIGS. 43 and 44 are graphs for the involuntary reflex cough test for asubject demonstrating neuro decline over a 1.5 year period in which themarked decline in iRCT measured variables helps determine medicalmanagement.

FIGS. 45-47 are graphs for the reflex cough test, CMG with EMG from theL5/S1 midline paraspinal muscles as a normal iRCT/LER test.

FIG. 48 is a graph showing abnormal test as a comparison to the normaltest shown in FIGS. 44-46.

FIG. 49 is a flowchart showing a tube feeding status and subsequentinfection rate.

FIG. 50 is a bar chart showing time-to-infection data for survivors whowere tube fed and developed infections after stroke.

FIGS. 51 a through 51 e are figures showing an oral-esophageal andgastric catheter (NG/OG device) with an esophageal device to reduce ordiminish gastric reflux and/or emesis in surgical, neurological and/ortrauma patients in accordance with a non-limiting example.

FIGS. 52 a through 52 g are figures showing another embodiment of theoral-esophageal gastric device similar to that shown in FIGS. 51 a-51 cbut having a nebulizer function, pH sensing and pressure sensing.

FIG. 53 is a plan view of a catheter that can assess the severity ofreflux and compare a response of the involuntary reflex cough test andmagnitude in accordance with a non-limiting example.

FIGS. 54 a, 54 b and 55 to 58 are figures detailing what occurs duringLER and involuntary cough and showing nerve conduction pathways.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention will now be described more fully hereinafter withreference to the accompanying drawings, in which preferred embodimentsof the invention are shown. This invention may, however, be embodied inmany different forms and should not be construed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art. Likenumbers refer to like elements throughout.

FIG. 1 shows a flowchart of a technique for evaluating a patient forurinary stress incontinence in accordance with one aspect of theinvention. As an initial step, pressure sensing catheter is insertedinto a patient's empty bladder (100). The patient's bladder is thenfilled slowly with sterile water until 200 ml have been delivered (110).

The patient is then asked to voluntarily cough (120) and the results ofthe voluntary cough are recorded (130) by recording the variations inpressure as a function of time and by recording whether or not the coughinduced involuntary expulsion of urine. See item 130.

Then, a reflex cough test is performed (140) and the results arerecorded in a manner substantially similar to step 130. Details of thereflex cough tests are discussed more in conjunction with FIG. 2.

FIG. 2 shows a flowchart of a technique for conducting a reflex coughtest. With the test arrangement in place as described in conjunctionwith items 100 and 110 of FIG. 1, instead of asking a patient tovoluntarily cough, the patient is administered a nebulized compositionof L-tartrate in a pharmaceutically acceptable carrier (200). Thevariations in bladder pressure that occur during the involuntary coughsinduced by step 200 are then recorded and plotted for display (210). Thepatient is checked for any urinary leakage that occurs during theinvoluntary coughs (220).

FIG. 3 shows a catheter that can be used for carrying out variousaspects of the invention. A catheter, 300, includes a pressure sensor310 and conductive wires or paths which conduct the electrical output ofthe pressure sensor 310 to external circuitry. The wires or paths arehereinafter called pressure sensor leads 320. The catheter lumen can beutilized to fill or drain the patient's bladder as appropriate. Examplesof a catheter usable in accordance with the invention may include aFoley catheter equipped with a pressure sensor.

FIG. 4 is an illustration of a handheld processing device that can beused to carry out the invention. As shown on the device display screen,the variation in pressure that occurs as a function of time during avoluntary or involuntary cough is displayed.

FIG. 5 is a block diagram of an exemplary processing device as part ofthe handheld device that can be utilized to carry out aspects of theinvention. FIG. 5 is a block diagram that illustrates a computer system500 upon which an embodiment of the invention may be implemented.Computer system 500 includes a bus 502 or other communication mechanismfor communicating information, and a processor 504 coupled with bus 502for processing information. Computer system 500 also includes a mainmemory 506, such as a random access memory (RAM) or other dynamicstorage device, coupled to bus 502 for storing information andinstructions to be executed by processor 504. Main memory 506 also maybe used for storing temporary variables or other intermediateinformation during execution of instructions to be executed by processor504. Computer system 500 further includes a read only memory (ROM) 508or other static storage device coupled to bus 502 for storing staticinformation and instructions for processor 504. A storage device 510,such as a magnetic disk or optical disk, is provided and coupled to bus502 for storing information and instructions.

The interface 518 receives signals from pressure transducers connectedto catheters inserted through the urethra and/or rectum and othersignals, for example, EMG (electromyogram) signals such as taken fromthe paraspinal muscles as explained in greater detail below. EMG signalscan be processed alone without catheter processor signals.

Computer system 500 may be coupled via bus 502 to a display 512, such asa cathode ray tube (CRT), for displaying information to a computer user.An input device 514, including alphanumeric and other keys, is coupledto bus 502 for communicating information and command selections toprocessor 504. Another type of user input device is cursor control 516,such as a mouse, a trackball, or cursor direction keys for communicatingdirection information and command selections to processor 104 and forcontrolling cursor movement on display 512. This input device typicallyhas two degrees of freedom in two axes, a first axis (e.g., x) and asecond axis (e.g., y), that allows the device to specify positions in aplane.

Computer system 500 operates in response to processor 504 executing oneor more sequences of one or more instructions contained in main memory506. Such instructions may be read into main memory 506 from anothercomputer-readable medium, such as storage device 510. Execution of thesequences of instructions contained in main memory 506 causes processor504 to perform the process steps described herein. In alternativeembodiments, hard-wired circuitry may be used in place of or incombination with software instructions to implement the invention. Thus,embodiments of the invention are not limited to any specific combinationof hardware circuitry and software.

The term “computer-readable medium” as used herein refers to any mediumthat participates in providing instructions to processor 504 forexecution. Such a medium may take many forms, including but not limitedto, non-volatile media, volatile media, and transmission media.Non-volatile media includes, for example, optical or magnetic disks,such as storage device 510. Volatile media includes dynamic memory, suchas main memory 506. Transmission media includes coaxial cables, copperwire and fiber optics, including the wires that comprise bus 502.Transmission media can also take the form of acoustic or light waves,such as those generated during radio-wave and infra-red datacommunications.

Common forms of computer-readable media include, for example, a floppydisk, a flexible disk, hard disk, magnetic tape, or any other magneticmedium, a CD-ROM, any other optical medium, punchcards, papertape, anyother physical medium with patterns of holes, a RAM, a PROM, and EPROM,a FLASH-EPROM, any other memory chip or cartridge, a carrier wave asdescribed hereinafter, or any other medium from which a computer canread.

Various forms of computer readable media may be involved in carrying oneor more sequences of one or more instructions to processor 504 forexecution. For example, the instructions may initially be carried on amagnetic disk of a remote computer. The remote computer can load theinstructions into its dynamic memory and send the instructions over atelephone line using a modem. A modem local to computer system 500 canreceive the data on the telephone line and use an infra-red transmitterto convert the data to an infra-red signal. An infra-red detector canreceive the data carried in the infra-red signal and appropriatecircuitry can place the data on bus 502. Bus 502 carries the data tomain memory 506, from which processor 504 retrieves and executes theinstructions. The instructions received by main memory 506 mayoptionally be stored on storage device 510 either before or afterexecution by processor 504.

FIG. 6 is a flowchart of software used to program a processing device inaccordance with one aspect of the invention. The processing device isprogrammed to repetitively sample pressure output from the sensor (600).Upon receipt of an initiation or start signal, the processor can startrecording data from the pressure sensor (610). The start signal can begenerated by utilizing either a rapid increase in pressure, by detectinga pressure threshold being exceeded, or by receiving a trigger signalinitiated by a user. Such a signal was discussed in conjunction withU.S. patent application Ser. No. 10/783,442, filed Feb. 20, 2004,entitled Apparatus For Evaluating A Patient's Laryngeal Cough Reflex AndAssociated Methods, by W. Robert Addington, Stuart Miller and RobertStephens, referred to above.

After receipt of the starts signal, the processing unit stores thesamples and displays the plot of the pressure sample values (620).

Upon completion of the cough sequence, software is programmed tocalculate the area under the curve of a plot of the sample values (630).The areas under the curve (AUC) values are calculated by the numericalintegration of intravesical pressure over time with either Simpson's3/8-rule or Bode (or Boole's) rule. Both Simpson's 3/8-rule and Bode (orBoole's) rule are methods of numerical integration that yield moreaccurate results for AUC than the trapezoidal method.

Simpson's 3/8 Rule:

${{\int_{\alpha}^{\beta}{{f(x)}{\mathbb{d}x}}} \approx {\frac{3h}{8}\begin{Bmatrix}{f_{0} + f_{n} + {3\left( {f_{1} + f_{4} + \ldots + f_{n - 2}} \right)} +} \\{{3\left( {f_{2} + f_{5} + \ldots + f_{n - 1}} \right)} +} \\{2\left( {f_{3} + f_{6} + \ldots + f_{n - 3}} \right)}\end{Bmatrix}}} = {\frac{3h}{8}\begin{Bmatrix}{{f(\alpha)} + {f(\beta)} + {3{\sum\limits_{{i = 1},4,7,\;\ldots}^{n - 2}{f\left( {\alpha + {ih}} \right)}}} +} \\{{3{\sum\limits_{{i = 2},5,8,\ldots}^{n - 1}{f\left( {\alpha + {ih}} \right)}}} + {2{\sum\limits_{{i = 3},6,9,\ldots}^{n - 3}{f\left( {\alpha + {ih}} \right)}}}}\end{Bmatrix}}$

Bode's (Boole's) Rule:

${\int_{x_{1}}^{x_{s}}{{f(x)}\ {\mathbb{d}x}}} = {{\frac{2}{45}{h\left( {{7\; f_{1}} + {32f_{2}} + {12f_{3}} + {32f_{4}} + {7f_{5}}} \right)}} - {\frac{8}{945}h^{7}{{f^{(6)}(\xi)}.}}}$

All AUC values were calculated using Bode's (Boole's) rule, except forthat of Patient #1, which was calculated with Simpson's 3/8-rule. Bode's(Boole's) method was not very adept at handling as few data points (3).

The process may selectively display the calculated area under the curveto the user either with or separately from display of the plot of thesample values (640).

Optionally, one may output the raw and calculated data for use outsideof the processing device (650). This can be done utilizing interface518.

FIGS. 7A and 7B illustrate test results comparing voluntary cough andinvoluntary cough techniques for assessing stress urinary incontinence.

The testing that produced the results shown in FIGS. 7A and 7B aredescribed as follows.

Objective: the Objective of this Study were to:

1) Evaluate the effectiveness of the reflex cough test (RCT) versusvoluntary cough in confirming stress urinary incontinence in femalesubjects with a history of mild urinary incontinence as determined bythe Incontinence Quality of Life Instrument (I-QOL); and

2) Correlate, if indicated, intravesicular pressure measurements withurinary leakage after RCT.

Materials and Methods: Voluntary and involuntary (RCT) cough provocationmaneuvers were performed during urodynamic testing in 6 women. Fourwomen had a history of mild stress urinary incontinence and two werenormal controls. The order of the cough provocation procedures wasrandomized.

Prior to urodynamic assessment, subjects were instructed to empty thebladder (confirmed via ultrasound). Using sterile technique, calibratedbladder and rectal catheters were placed and continuous dual-channelpressure recording was performed and the subject's bladder was filledslowly with sterile water until 200 mL had been delivered.

Cough Leak Point Pressure (CLPP) was assessed with a bladder volume of200 mL. Leakage was determined by visual inspection of the perineum bythe Investigator during the coughs, and electronically marked on theprint-out. If the subject did not leak with either cough maneuver in thesemi-recumbent position, the standing position was used. Urodynamictesting was completed with filling to capacity to observe for detrusorinstability.

After instruction, subjects performed a maximal forceful voluntary cough(VC) and an involuntary cough. The involuntary cough was elicited bystimulating the laryngeal cough reflex by performing the RCT with thepatient's nose held closed. The RCT involves inhaling a concentration of20% L-(+)-tartaric acid dissolved in normal, sterile saline (NephronPharmaceuticals, Orlando, Fla.) delivered via jet nebulizer.

An independent reviewer used the continuous pressure recording of eachsubject to determine peak pressures, measure duration of the coughevents, count the number of pressure spikes, and derive area under thecurve (AUC) numbers.

Results: Peak pressures were similar when comparing voluntary cough withthe RCT (FIGS. 7A and 7B). Duration of cough events, AUC, and number ofspikes were all increased with RCT relative to voluntary cough. Neitherof the 2 normal subjects leaked with either cough maneuver. Of the 4subjects with mild stress urinary incontinence (diagnosed by I-QOL), 3leaked with RCT and 2 leaked with VC. A possible carryover effect wasidentified when assessing subjects that were randomized to undergo RCTtesting prior to VC. There appear to be a relative increase in AUC, peakpressure, duration, and in the number of spikes with VC testing whenvoluntary cough testing was performed after, rather then prior art to,the RCT (FIGS. 7A and 7B). It is notable that both subjects that leakedwith voluntary cough were randomized to have the RCT performed first.

RCT provides considerable “stress” in subjects with stress urinaryincontinence and appears to be a useful involuntary maneuver ineliciting leakage in subjects with this condition. No other involuntarymaneuver has been studied in evaluating this condition. The datasuggests that RCT may be more efficient in provoking leakage in subjectswith stress urinary incontinence than voluntary cough.

FIG. 8 is a block diagram of a processing device 500 as part of thehandheld device similar to that shown in FIG. 4, but showing a wirelessmodule 550 and antenna 552, which communicate wirelessly to a wirelesssensing device 560. The wireless sensing device includes a wirelesstransceiver 562, processor 564 and interface 566 that connects tocatheters or other input devices such as an EMG signal input obtainedthrough ENG pads and associated components located at the paraspinal,for example, in a preferred embodiment. Data is transmitted usingwireless communications signals via the transceiver 562 and antenna 570to the handheld device that incorporates the processing device 500. Dataprocessing is accomplished in the handheld device using appropriatecircuitry as described before.

There now follows greater details of the involuntary reflex cough usednot only for accessing stress urinary incontinence, but also for use asa medical diagnostic tool in accordance with non-limiting examples.

There now follows a general description of physiology for theinvoluntary reflex cough test (iRCT), which activates the NucleusAmbiguus. The iRCT selectively activates the Medial Motor Cell Column(MMCC) of the spinal cord rather than the (Lateral) LMCC to fire musclesembryologically predetermined to be involuntary cough activated musclesin the pelvis. In the past, urologists did not selectively activate MMCCwithout overtly activating the LMCC. Magnetic stimulation or electricalspinal cord stimulation activate both cell columns and thus it is notpossible to sort out pathology with these. Magnetic stimulation or otherapproaches from CNS activation set off both columns.

The pelvic muscles that typically are activated with MMCC coughactivation include the lumbar-sacral L5/S1 paraspinal axial musculature,which facilitates inpatient continence screening. An example is throughMMCC iRCT muscle activation, obtaining L5/S1 paraspinal firing but notL5/S1 lateral gastrocnemius activation because the gastroc muscles arelimb muscles activated primarily through the LMCC.

The L-S paraspinals are easier to access with a large pad placed abovethe sacrum on the midline that contains active, reference and groundcombined. It is not important to determine lateralization of theactivity like needle EMG for radiculopathy, but only if activationoccurs reflexively where the onset latency is under the pressureactivation of the abdomen such as the Levator Ani. This is a poor musclefor these purposes because people train it to activate and set theirpelvis if the person senses any intra-abdominal pressure elevation.Also, it is difficult to get pads to stick to that area with hair,perspiration, fungal infections or bowel/bladder incontinence present,and other factors.

Some examples have been developed and studied, including a normal CNSpatient with Lumax bladder and bowel catheters and pads at L5/S1paraspinals and a separate EMG machine and electrodes at the pelvicfloor in a standard 3:00 and 9:00 o'clock set-up to demonstratesimultaneous involuntary activation with iRCT. This sets off the pelvicfloor muscles. Thus, normal airway protection data is obtained andnormal CNS data to L1 (where spinal cord ends). The set-up includes acomplete T12 that cannot void and needs intermittent catheterizationwith the same set up, thus demonstrating data for normal airway but noL5/S1 EMG activation by MMCC with all the other data necessary to provean unsafe bladder by the algorithm. A quadriplegic can demonstrateabnormal airway protection and abnormal EMG activation at bothparaspinal and pelvic floor muscles with unsafe bladder measurementsthat follow the algorithm.

It should be understood that iRCT is an involuntary maneuver thatactivates embryologically predetermined muscles for airway protectionand continence that travel primarily through the MMCC in the spinalcord. Different varieties of lesions are captured and determined withsummated interval data approach for general screening purposes.

There now follows an initial study of the iRCT test results relative toSUI and followed by detailed examples showing support for iRCT todetermine SUI and for neurophysiological analysis and showingprogressive understanding of the advantageous use of the iRCT.

It is known that the laryngeal cough reflex (LCR) is a strongbrainstem-mediated reflex that protects the upper airway by preventingaspiration, or the entrance of secretions, food, and/or fluid into theairway below the level of the true vocal cords (rima glottidis), throughelicitation of an involuntary cough. The LCR is activated through thestimulation of cough receptors in the vestibule of the larynx. One waythis is achieved is through the inhalation of chemostimulants, such astartaric acid. Studies have shown that if the LCR is intact, the subjectwill involuntarily cough (normal LCR) upon inhaling a solutioncontaining TA.

In one non-limiting example, the iRCT involves the inhalation of anebulized 20% normal saline solution of L-TA (Tartaric Acid). Subjectsare asked to perform 1 to 3 effective, full inhalations (about 15-20second exposure by mouth for tidal breathing wearing a nose clip) from astandard jet nebulizer with at least 50 psi from an oxygen wall unit ortank that produces an average droplet diameter of 1 to 2 microns orless. The nebulizer output is 0.58 mL/min. The initiation of aninvoluntary cough reflex after any one of the inhalations is the endpoint of the procedure.

Nebulized TA is a chemical tussive that stimulates irritant receptors inthe mucosa of the laryngeal aditus. Mild irritation of these receptorsresults in nerve impulses being conveyed by the internal branch of thesuperior laryngeal nerve (ibSLN) to bulbar centers of the brainstem.This nerve constitutes the afferent sensory component of the LCR arc.The efferent component of the LCR is mediated through the vagus,phrenic, intercostals and thoracoabdominal nerves.

Inhaled TA is selective in stimulating rapidly adapting (“irritant”)receptors (RARs), in the supraglottic region. In humans, bilateralanesthesia of the ibSLN abolishes TA-induced cough and permits tidalbreathing of the nebulized vapor without coughing, supporting the ideathat the RARs are responsible for TA-induced cough.

The physiological response from inhalation of TA in a normal subject isabrupt, forceful coughing of short duration. Using a 20% solution ofinhaled nebulized TA is a safe, reliable way to assess the sensation inthe supraglottic laryngeal region and subsequently the neurologiccircuitry of the LCR. In addition, the ability of the iRCT to predictthe integrity of the protective LCR in subjects with stroke has beenstudied.

A 20% solution of TA as an aerosol causes cough by stimulating sensorynerves in and under the laryngeal epithelium. These nerves have beenidentified histologically, and the reflexes they cause have beenidentified. The sensory nerves can be stimulated by both non-isosmolarand acid solutions. Tartaric acid may act in both ways, but the balancebetween them is uncertain.

The nerves are stimulated by the opening of membrane channels in thenerve terminals. More than 20 categories of channels have now beenidentified, the opening of which will allow calcium flow into the nerve(and also sodium, with exit of potassium), with the result that anaction potential is set up, which travels to the brainstem in thecentral nervous system (CNS), and reflexively induces cough.

Several different types of sensory nerve ending in the larynx have beenidentified that may mediate cough and other defensive reflexes. Theyhave been extensively studied, mainly in experimental animals byrecording the action potentials in their nerve fibers. The probablecandidates for cough are the RARs or ‘irritant’ receptors. These arehighly sensitive to mechanical stimuli, to hyperosmolar solutions, andto acids.

Once stimulated, the sensory nerves will induce a variety of defensivereflexes which protect the lungs from invasion of harmful material.These include cough (an inspiration, followed by a forced expirationagainst a closed glottis, followed by opening of the glottis with anexpiratory blast); the laryngeal cough expiratory reflex (LCER, apowerful expiratory effort with the glottis open); and the glottalclosure reflex. In some instances a reflex apnea can be produced. Thebalance of these reflexes may depend on the nature and the strength ofthe stimulus. In the case of TA, the LCER seems to be dominant, possiblyfollowed by glottal closure, and the pathophysiological advantage ofthis response in preventing aspiration is obvious.

There is clinical experience in subjects with stress urinaryincontinence. A pilot study was initially designed as a single-center,single-blind study to evaluate the effectiveness of the iRCT in inducingan involuntary cough that would confirm urinary leakage in femalesubjects with a history of mild SUI. Up to 3 inhalations of a 20%sterile, aqueous solution of TA delivered via an ultrasonic jetnebulizer with oxygen at 50 psi to deliver droplets of ≦1 μm wereadministered to yield a reflex cough. The primary endpoint was theobservation of urinary incontinence in subjects with a history of mildSUI during iRCT and a lack of urinary incontinence in normal subjects.Secondary endpoints were documentation of bladder and abdominalpressures and tolerability of iRCT.

The initial enrollment was 6 women (18-75 years of age), including 4women with a history of mild SUI as determined by the IncontinenceQuality of Life Instrument (IQOL) and 2 healthy controls with no historyof SUI. However, the protocol was amended to increase total enrollmentfrom 6 to 9 subjects (7 with SUI and 2 healthy controls).

The study protocol assessed the two cough provocation maneuvers(voluntary cough test and iRCT) for each subject. The order of the coughprovocation was randomized but each subject completed both tests. Theprotocol was subsequently amended to remove blinding and randomizationfrom the study and all subsequently enrolled subjects underwent VCTfollowed by iRCT followed by a second VCT. Subjects underwent theprovocation maneuvers within 30 days of screening and then had twofollow-up visits: the first 1 to 5 days after treatment; the second 5 to7 days after treatment.

Urodynamic evaluation was done during each cough maneuver. Theparameters determined during this evaluation included maximal urethralpressure (MUP), maximal abdominal pressure (MAPP), maximal detrussorpressure (MDPP), maximal abdominal leak point pressure (MALPP), maximaldetrussor leak point pressure (MDLPP), and CLAP.

A total of 9 subjects were evaluated, 2 without SUI and 7 with a historyof mild SUI. All subjects enrolled in this study were white and not ofHispanic or Latino background. Subject age ranged from 31 to 71 years.The mean subject age was 48.4 years: 51.0 years for healthy controls and47.7 years for subjects with SUI. Two (22%) subjects were smokers: 1(50%) healthy control and 1 (14%) subject with SUI. The remaining 7(78%) subjects were non-smokers.

Individual subject responses to the cough provocation tests aresummarized in Table 1. The two control subjects (#2 and #3) did not leakwith either VCT or iRCT. Of the remaining 7 subjects with mild SUI, only2 subjects (#8 and #4) did not produce leak with either VCT or iRCT. Twoother subjects (#5 and #6) produced leak with both VCT and iRCT. Theremaining 3 subjects (#1, #7, and #9) did not produce leakage with VCTbut did with the iRCT.

TABLE 1 Individual Subject Responses to iRCT and VCT: ProtocolPNEU-01-002 Urine Leakage? Subject Status VCT iRCT VCT 2 Normal No No —3 Normal No No — 1 SUI No Yes — 4 SUI No No — 5 SUI Yes Yes — 6 SUI YesYes — 7 SUI No Yes No 8 SUI No No No 9 SUI No Yes No VCT, voluntarycough test; iRCT, induced cough reflex test; SUI, stress urinaryincontinence.

The performance of the cough provocation procedures is presented inTable 2. Sensitivity of the cough provocation maneuvers was 71.4% duringiRCT and 28.6% during VCT. Specificity was 100% during iRCT and VCT. Thepositive predictive value (PPV) was 100% for iRCT and VCT; the negativepredictive value (NPV) was 50% for iRCT and 28.6% for voluntary cough.

TABLE 2 Performance Statistics of the Cough Procedures: EvaluablePopulation Voluntary Cough Reflex Cough N = 9 N = 9 Sensitivity¹, n/N(%) 28.6 71.4 Specificity², n/N (%) 100 100 PPV³, n/N (%) 100 100 NPV⁴,n/N (%) 28.6 50 PPV, positive predictive value; NPV, negative predictivevalue; TP, true positive; FN, false negative; TN, true negative; FP,false positive. ¹Sensitivity = TP/(TP + FN) ²Specificity = TN/(TN + FP)³PPV = TP/(TP + FP) ⁴NPV = TN/(TN + FN) The evaluable population wasdefined as all subjects who met study entry criteria and completed allcough maneuvers. For subjects enrolled after Protocol Amendment 1, datafrom the first voluntary cough was used.

The urodynamic parameters were summarized and there was a trend forincreased mean abdominal pressure (cm H₂O) and mean detrussor pressurewhen the subjects were administered the iRCT compared with the VCT. TheCLPP was not consistently higher after iRCT compared with after VCT.

The trend for an increase in abdominal and intravesicular pressuresafter the iRCT compared with the VCT in those subjects who experiencedleakage suggests that the iRCT causes significant stress on thesphincter, resulting in urinary leakage.

Analysis compared a digitized area under the pressure curve (AUC) afterthe iRCT, and after VCT was also conducted. Digitization of thepressure-time curve from the recordings allowed quantification of thestress generated during the cough procedures. Using the averageintravesicular pressure (P_(ves)) values, AUC values were calculated bythe numerical integration of P_(ves) over time with either Simpson's3/8-rule or Bode (or Boole's) rule. There was a trend for higher peakP_(ves) and greater AUCs in subjects after iRCT compared with Z. Theresults show that the iRCT provides a larger and more robust stress thanVCT. The relatively increased value of AUC measurements with iRCT are agood numerical representation of the magnitude of stress placed on theurethral sphincter and offers an explanation for the increased number ofsubjects with mild SUI that leaked with iRCT when compared to VCT.

These results, combined with the urinary leakage observed after theiRCT, show that the iRCT has clinical utility in producing astandardized cough that allows for a definitive diagnosis of SUI aslater explained in greater detail with further results.

No AE's occurred during this study and no clinically significantlaboratory abnormalities were noted. No subjects discontinued from thestudy for any reason. The iRCT procedure was safe and tolerable to thesubjects in this study.

In summary, three out of five women (60%) with SUI experienced urinaryleakage only after the iRCT while two of the SUI subjects (40%)experienced urinary leakage after both the iRCT and VCT. Neither of thetwo healthy control subjects experienced urinary leakage after eitherthe iRCT or VCT. Based on these initial results, the iRCT is morespecific and sensitive than the VCT, indicating that iRCT isadvantageous in the diagnosis of SUI.

There now follows an analysis and test results in greater detail thatexplain the advantageous use of the involuntary reflex cough test (iRCT)for investigating and diagnosing not only SUI but also physiologicalabnormalities such as neurologic deficiencies. It should be understoodthat there are differences between normal and neurological patients.

As noted before, there are ranges and boundaries with parameters thatare now used to establish a normal neurological range. Some of thegraphs representative of urodynamic testing as explained below show adelay between the EMG muscle activity and actual occurrence of a leak.In one non-limiting example, it is no more than a few milliseconds (six)in some examples between when the patient coughs and the leak occurs.The EMG corresponds to the electromyogram test and detects muscleelectrical activity. It can be displayed visually on an oscilloscope anddetected with signal peaks in a non-limiting example.

It is possible to conduct a Nerve Conduction Velocity (NCV) test asverification, and if there is a large delay, for example, sixmilliseconds, in one aspect, it could correspond to a neuropathologicalproblem. In accordance with a non-limiting example, the involuntaryreflex cough test (iRCT) is useful as a medical diagnostic tool andpermits analysis of neuropathological problems. The involuntary reflexcough test also is used for analyzing stress urinary incontinence. Adata processing methodology based on urodynamic testing and useful withthe handheld device as described above is later set forth. A methodologyfor stress urinary incontinence analysis using the handheld device forexample, is explained relative to the flowcharts of FIGS. 23-26. Theinvoluntary reflex cough test as explained can be used as a standardizedtest in conjunction with the data processing as described. This isdistinctive from an analysis using a voluntary cough in which a patienthas time to set their pelvis. Processing EMG data also is accomplishedin some examples in which the EMG is taken from the paraspinal insteadof the perineal.

The EMG from the perineal muscles respond almost simultaneously to theonset of the voluntary cough because the patient does not want to leak.With the involuntary reflex cough test, on the other hand, the fastfibers that are set off reach the abdominal muscles quickly, such as in17 milliseconds as an example. The patient is not able to set theirpelvis. In some of the graphs reflecting urodynamic testing as will bedescribed, it is evident that the onset of the EMG activity does nothappen at the same time the pressure rises. Some people that haveneuropathy, for example, spinal stenosis or nerve injury (even if it ismild), have a situation that prevents the reflexes from closing beforethe pressure has changed to push on the bladder. It is not possible toobtain this diagnostic tool methodology unless the involuntary coughreflex test is accomplished. When the involuntary reflex cough test isaccomplished, it is possible to demonstrate a latency delay and showthat the pathophysiology is a neuropathic problem rather than astructural problem. It is possible to separate the pathophysiology usingthe involuntary reflex cough test and methodology as described.

In one example, a female patient could have a weak spinal cord and herphysiology is normal. This patient may not leak during the test, but thepatient cannot protect her airway. Thus, using the methodology apparatusand system associated with the involuntary reflex cough test, inaccordance with non-limiting examples, it is possible not only todiagnose an unprotected airway, but also to diagnose normal bladderphysiology, including the neurophysiology to the patient's sphincterclosure process. This is advantageous because it is then possible todetermine when someone cannot protect their airway, even though they mayhave a normal bladder. Conversely, there are patients with a normalairway, but cannot control their bladder. This process and system asdescribed is able to make that diagnosis and thus the involuntary reflexcough test is an advantageous medical diagnostic tool. For example, itis possible to have a patient with a poorly functioning bladder andnormal airway and use of the test allows a doctor to find lower urinarytract symptoms and neuropathology. It becomes possible to diagnose alevel of lesion in a patient with a full comprehensive neurologicexamination using the involuntary reflex cough test, methodology andapparatus as described.

As will be described in detail later, the various components such as thenebulizer, one or more catheters, any pads for the paraspinal muscleswhen EMG is used, and drug as part of the nebulizer are inserted in akit for use at the clinic, hospital or in-patient setting. Thosecomponents can be discarded after use. The handheld device, of course,will be used again. Use of the kit provides a clinician, doctor or othermedical professional the readily available diagnostic tool to determineif a patient has a questionable airway and determine bladder physiologyat the same time, all with the use of the one kit.

The EMG component of the waveform is typically important for analysis asexplained. Two catheters are used in some analysis, one for the rectumor vagina and one for bladder. In another example one catheter is used.In yet another example, no catheter is used. EMG is taken from theparaspinals. In examples, the intravesicular pressure is important incombination with EMG taken at paraspinals. The EMG is correlated withpressure (e.g., intravesicular pressure) and a delay component. In thepreferred method, the EMG is taken from the paraspinal muscles to obtaina clean signal where EMG sensors are placed on the back at the spine. Inconjunction with the clean EMG signal obtained from the paraspinalmuscles, it is possible to obtain the representation of where theinvoluntary cough event “take-off” starts and where it ends. Thehandheld device includes a processing device such as a microprocessorand appropriate software that correlates the data. It is possible toobtain a diagnosis for the level of lesion in a patient, while alsoobtaining a full comprehensive neurophysiological examination as notedbefore. Data is obtained from the involuntary reflex cough test and fromthe EMG. In one aspect depending on the type of desired analysis, acatheter is used in a non-limiting example to obtain the intravesicularpressure (P_(VES)).

Referring now to the graphs for the urodynamic testing shown in FIGS. 9and 10, there is illustrated time in seconds (horizontal axis) for theinvoluntary cough reflex test event and the various componentscorresponding to the vesicular pressure, abdominal pressure (P_(VES)),detrusor pressure, and the EMG on the vertical axis. FIG. 9 showsresults for involuntary reflex cough tests when the EMG signal is takenfrom the perineal. Electrodes were placed at the 3:00 and 9:00 o'clockpositions near the anus for the EMG taken from the perineal. FIG. 10shows the involuntary reflex cough test using lumbar electrodes at theL5/S1 for EMG. In these examples, the EMG's were taken from a patientthat cannot void following an L-S laminectomy and fusion. This patienttolerated filling the 200 millimeters and had a stress urinaryincontinence history and stress urinary incontinence on the involuntaryreflex cough test. The patient could not void despite the stress urinaryincontinence and had low voiding pressures after filling to 350 ml,hypotonic bladder. This was a unique mix of hypotonic bladder and SUI,but otherwise no overflow incontinence. These graphs show that a betterdetermination is made for the iRCT (involuntary reflex cough test) andEMG signal results from the L5/S1 paraspinal with a current Lumax EMGbaseline. L5 corresponds to the last vertebrae in the lumbar spine andS1 corresponds to the first vertebrae in the sacral spine.

It should be understood that a Foley catheter could block the urethra. Asmaller catheter is preferred to measure such as described relative tothe catheter of FIGS. 31 and 32 in one non-limiting example. Somestudies indicate that a poorly sized catheter could otherwise blockthose patients that would leak using the involuntary reflex cough test,but otherwise would not leak because of the larger catheter placementand its concomitant blocking. A smaller catheter as will be discussedlater is desirable in these instances to measure pressure and serveother functions. In one example, a catheter is used for bladder screenand airway protection diagnosis, while for stress incontinencedetermination, a catheter may not always be necessary and a pad fordetermining when leakage occurs is used.

A kit that is marketed for the iRCT diagnostic tool could include thenebulizer and its drug as TA in one example and one or more pads for theelectrodes at the paraspinal and use with EMG. The pad may only benecessary for stress incontinence determinations. A catheter is includedin another kit example for use in measuring airway and intra-abdominalpressure. In one non-limiting example, a pad can be placed on a catheterto determine urine leakage and aid in determining stress incontinence.Pressure data is sent to the handheld device in some examples. Obtainingany EMG values from the paraspinal in conjunction with the urologyanalysis is advantageous. It is possible in one example to measurepressure from a bladder catheter and determine at the same time EMGsignals using the EMG electrodes at the L5/S1 in conjunction with themeasured involuntary reflex cough test and urology catheter sensing.This is advantageous compared to placing electrodes at the perinealmuscles on each side of the anal sphincter. The graphs in FIGS. 9 and 10show the disadvantage of the perineal EMG where interference is obtainedas shown in FIG. 9 for the perineal as compared to FIG. 10 for the L5/S1as described above.

It has been found that EMG signals obtained from the perineal muscleshave EMG activity from the non-involuntary muscles, i.e., the voluntarymuscles blacking out and making analysis difficult because of the signalinterference. When the electrodes are placed at the back at the L5/S1junction, on the other hand, there is nothing else but the paraspinalmuscles. It is bone below on each side at the L5/S1 junction. Theelectrical impulses can be obtained that determine the number of coughimpulses coming down through the patient. This is accomplished even if aperson has much adipose. The electrode pad used at the L5/S1 junction,in one non-limiting example, typically has an active reference andground. A pad holds this active reference and ground and the leads asthe active reference and ground are plugged into the handheld device (orwireless sensing device in another example) and transmit data to theprocessor. At least one catheter is also plugged into the handhelddevice (or wireless sensing device) and measures bladder pressures. Arectal catheter can also be used in some examples. The processorreceives EMG signals and determines when the cough event is over.

The involuntary coughs are not hidden by interference when measured fromthe lower back at the paraspinals as described. This allows a clinicianto determine coughs from the bladder when the EMG is located at theL5/S1. In one aspect, the area under curve and the average pressure isdetermined for the cough event corresponding to the involuntary reflexcough test. When this involuntary component of the cough ends, in oneexample, it becomes silent EMG activity for a period of time. Thepressures are at baseline for a period of time, which corresponds in oneexample to an inhalation. The involuntary component is over.

Sometimes with the involuntary reflex cough test, the cough occurs sixtimes without breathing, but when the patient stops to breathe, theevent is over. Using the programming applied with the processor in thehandheld device, it is possible to calculate the variables inside thewave as to the involuntary cough and determine airway protectioncapability. Thus, it is possible to determine and measure cough bydefining through appropriate data processing the involuntary cough eventcompared to the whole cough epoch. For example, a patient could coughten times, but only the first four are part of the involuntary coughevent. The coughs after that event are not part of the epoch.

The graphs for urologic testing in FIGS. 9 and 10 show the EMG signalcomponent (EMG), detrusor pressure (P_(DET)), abdominal pressure(P_(ABD)) and vesicular pressure (P_(VES)). Obtaining the detrusorpressure is not always necessary, thus the set up may not require therectal and urethral catheters. The analysis can be accomplished with theEMG signal component and vesicular pressure component such thatapparatus used for obtaining the vesicular pressure are used. Theintravesicular is often used to determine the intra-abdominal since bothtrack closely. Data from the pressure measurements and EMG inconjunction with the involuntary cough reflex test are capable togetherwith appropriate processing to assess for an unsafe bladder. There couldbe more continuous EMG activity in an unsafe bladder because thatcorresponds to an uninhibited muscle from a spinal cord injury or uppermotor neuron injury.

As will be explained, the programming includes algorithm branchesresulting in a conclusion of unsafe bladder based on the data analysis.It is possible to calculate from the waveforms information necessary forassessing airway protection ability. It should be understood that takingthe EMG from the L5/S1 is also a better situation for the doctor orclinician, and the patient, since it is more acceptable in a hospital,outpatient or inpatient setting. The doctor or clinician does not haveto bend down or stoop and look near the crotch area and place pads sincethe EMG can now be taken from the paraspinals. Also, the placement ofpads and electrodes at the paraspinals is advantageous when patients arestanding. If pads are placed at the perineal area, sweat and otherproblems could cause those pads to become loose and good signals may notbe obtained. Also, it should be understood that the perineal muscles donot fire involuntarily. The sphincter may fire involuntarily, but thatwould create more noise as noted before. Electrodes are not placed atthe anus, but are placed at the paraspinal area instead.

This information obtained from iRct and the EMG taken at the paraspinalsallows the doctor or clinician to obtain data leading directly to adiagnosis. For example, some patients that have urinary stressincontinence may have a normal airway in this analysis. It has beenfound by experimentation that the normal airway is about 50 centimeterswater average intra-abdominal pressure. It should be understood that thevesicular pressure (bladder pressure) can track intra-abdominal pressureand terms are often similar and used together. “Bladder” orintravesicular pressure is often used to determine and equate withintra-abdominal pressure. The two are sometimes used interchangeably.Stress urinary incontinence and/or bladder physiology can be diagnosed.The system and method as described leads directly to diagnosis. Fiftycentimeters average intra-abdominal pressure over time has been found tocorrespond to an involuntary reflex cough test normal airway. Thus, thestandard deviations or other percentages from that value are used in onenon-limiting example to determine an abnormal airway. In a conductedstudy, the actual value is determined to be about 50.6 centimeters wateras compared to voluntary cough values of about 48 centimeters of water.In an outpatient setting, it is possible to have the nebulizer (anddrug) and only a pad and test SUI. In hospitalized patients or inpatientsettings, this combination is used to measure airway and bladderphysiology and the test combination includes a catheter.

It should be understood that the involuntary cough reflex test (iRCT)gives a higher pressure average than obtained using a voluntary coughtest. The involuntary cough reflex test is thus a valuable medicaldiagnostic tool. In one example, four variables are significant in thisanalysis. These variables include: (1) duration of the event; (2)average intra-abdominal pressure of the event; (3) peak intra-abdominalpressure (max) of the event; and (4) area under the curve. Using thesefour variables, it is possible to process the received data and obtain aspecific diagnosis that could not otherwise be obtained without the useof the involuntary reflex cough test. Individual deficits in a specificvariable or combination of variables are used to characterize specificdiseases and problems and useful as a medical diagnostic tool.

Some specific examples obtained through experimentation follow. Forexample, FIG. 11 shows paired sample statistics, paired samplecorrelations, and paired sample tests for a neurologically normal groupof 168 patients and showing the average intra-abdominal pressure (AIAP)for the voluntary cough versus the involuntary reflex cough test. FIG.12 shows the results for the peak intra-abdominal pressure (PIAP) andFIG. 13 shows the results for the area under the curve (AUC).

FIGS. 14-16 are graphs showing a four-channel CMG with the voluntarycough test (VCT) and the involuntary reflex cough test (iRCT) andshowing the signal peaks and showing the EMG signal clarity better withthe RCT than with the VCT. In the voluntary cough test, the NIF was −40,indicating the difficulty with the voluntary cough test and theadvantageous use of the involuntary reflex cough test. This patientinitially had a tracheal tube, which is later removed. The tracheal tubewas out for the testing that was accomplished when the values shown inFIGS. 14-16 were obtained. The NIF as a negative inspiratory force of−40 (VCT) indicates a typical normal pulmonary parameter. This patient'smotor reflexes, however, do not work adequately and functions shut down.During testing, this patient could be sitting for 12 seconds and havedifficulty breathing and could in some cases develop acute respiratorystress syndrome or aspiration syndrome. This may require reintubation ina possible emergency situation. Otherwise, the patient could end upanoxic. It is evident that this process using the involuntary reflexcough test will help determine neurological processes (or deficits).

An analysis of the results in the tables of FIGS. 17A-17C allows abetter understanding of the differences between the voluntary cough testand the involuntary reflex cough test. This provocation of cough usingthe involuntary reflex cough test causes urinary incontinence insubjects with SUI who do not experience urinary incontinence withvoluntary cough. Alternatively, the involuntary reflex cough test doesnot produce urinary incontinence in healthy women without SUI. Theincremental portion of subjects with a history of SUI identified in thismatter are clinically useful in the diagnosis and management of SUI.This allows a determination of the Positive Predictive Value (PPV) andNegative Predictive Value (NPV) of the involuntary reflex cough testadministered with urodynamic testing (some data shown in FIGS. 17A-17C).Thus, it is possible to compare urodynamic parameters obtained during avoluntary cough and during the involuntary reflex cough test.

FIGS. 18 and 19 are graphs for urodynamic testing results showing datafor the involuntary reflex cough as a diagnostic tool in which theinvoluntary reflex cough test (iRCT) visualizes or quantifies sphincterdeficiencies with contrast of other quantification means. FIG. 18 showsthe test results when a voluntary cough test is administered for arecumbent patient and FIG. 19 shows the test results when theinvoluntary reflex cough test is administered for the recumbent patient.Various lines are indicated and described below.

FIGS. 18 and 19 are graphs that show a urodynamics event in this study.The Onset to Leak (OtL) in the graph is real time (Marks under L linesbelow L marks). The lines with a C at the top are retrospectively placedto identify peak pressure. The subject below was classified as mild SUI(M) by the investigator after exam and entry. The OtL is recorded asseconds from pressure take-off until the observer manually pushes abutton to indicate a leak is seen. The observer was blinded from themachine with a screen waist high, and the type of cough test beingadministered, VC vs iRCT, with noise cancelling headphones on. Theobserver was positioned below the waist and screen with headphones on towatch the urethral outlet and pushed the indicator line button when anobserved leak was seen, which marked the timeline.

The study did not have complete uniformity among sites. One site did notmark the leaks live during the event only if there was any leak at allwith one mark at the end outside the event. This site was not includedin the OtL Data Tables. Another nine sites marked the events the same,during the event when leakage was seen. These are relatively accurateand come only from pushing the button and cannot be marked as a leak (L)retrospectively by the sites. The number of times the button is pushedrepresents the individual urine leaks seen by the observer and may varyamong sites, but gives added information separating voluntary cough testand involuntary reflex cough test regarding the severity of SUI. Theline and pressure take off are live and if the marks are during theevent they are reasonably accurate with time lapse error from manuallypushing the button. This can be repeated in a small group with automaticsensors that would mark leakage more precisely. Regardless, the evidenceon the graphs shows significant differences in SUI between the voluntarycough test and involuntary reflex cough test (iRCT) for severity andmechanisms of action (MOA).

In FIG. 19, for example, iRCT, the test made the subject void, exceptthe Detrusor Line (Pdet) is not significantly elevating during theevent, which would be seen with voiding if the detrusor muscle iscontracting. It appears to be stress from outside the bladder andreflects the bowel catheter symmetrically for most of the event. If thenumber of leaks marked and the OtL represents pathophysiology, thispatient typically has at least Intrinsic Sphincter Deficiency (ISD), andthus, cannot be concluded from the leak marked on the VC event abovewhere the OtL is 7 seconds. Inhalation probably increases resting tonicclosure of the sphincters. This raises an issue whether the voluntarycough demonstrates that this inhalation activated tonic closure systemworks, by delaying the leak 7 seconds, while the iRCT points immediatelyto severe ISD (Intrinsic Sphincter Deficiency).

This is an example of why regardless if a person leaks on both voluntarycough and iRCT, it is not possible always to determine MOA or severityof SUI with voluntary cough. It is evidence of one reason overallimprovement in patient outcomes and quality of life have notsignificantly improved despite incontinence care, especially at thegeneral practice (GP) level. Thus, iRCT is a screening health tooluseful by the GP for early identification when conservative treatmentcould proactively help. iRCT is also a diagnostic tool useful by theurologists to assess severity, MOA and possibly intra-operatively andassist with sling or TVT tensioning.

This same approach may work in other sphincter deficiency situationssuch as Lower Esophageal Sphincter (LES) and reflux. It is possiblereflux laryngitis is initiated by an involuntary event, which combinedwith insufficiency of the closure system, leads to acid reflux whichwith laryngeal acid receptor activation continue the involuntary eventactivation and further unopposed reflux of acid. Visualization withcontrast may show significant reflux differences between voluntarycough, with inhalation tonic closure reinforcement, and iRCT activatedintra-abdominal pressure onset to reflux differences.

Further description concerning the involuntary reflex cough test as adiagnostic tool is now set forth. This is important not only for loweresophageal sphincter, but also for the urinary sphincter functionanalysis. The analysis as the chi-squared test can be accomplished by astatistician. This OtL data outcome for the voluntary cough test versusthe involuntary reflex cough test is in conjunction with lunch inflationwith tonic urethral and lower esophageal sphincters closure principle.This is an advantageous finding and is conclusive of why the involuntaryreflex cough test is an appropriate involuntary diagnostic maneuver as ahealth screen tool to improve outcomes, quality of life and decreaseneurological, urological and gastroenterological pathophysiology diseaseby improved diagnostic and measurable capabilities.

FIG. 20 shows tables for the statistical analysis (chi-squared) of thedata and information. This evidence shows that leak with iRCT occursearlier than with voluntary cough. There is some evidence that inflationof the lungs increases bladder sphincter closure and therefore mightinhibit leak. Lung inflation increases abdominal pressure that tendstowards leaks, which might be prevented by the additional bladdersphincter tone. Voluntary cough, unlike the iRCT, starts with aninspiration, and therefore there might be inhibition of leak in thefirst phase of voluntary cough. If this is so, leak should occur morefrequently in the first phase (initial expiratory effort) of iRCT thanin the first phase (inspiration) of voluntary cough.

Records of patients were checked in this process. Patients were locatedwho had a leak with either voluntary cough or iRCT or both, and who hada clear indication of the timing of the leak. Each leak was labeledeither as ‘early’ when it occurred during or immediately after the firstexpiratory phase of voluntary cough or iRCT, and as ‘late’ when itoccurred during or after the second expiratory phase of voluntary coughor iRCT.

The hypothesis was that if early leak occurred more frequently with iRCTthan with voluntary cough, this might be due to the leak-inhibitingmechanism in the inspiratory phase of voluntary cough, and could be afactor in explaining why time to leak (OtL) was greater with voluntarycough than with iRCT.

Records from 123 patients were analyzed. All leaked with voluntary coughor iRCT or both. Records were rejected when the leak time was notclearly identified. The distinction between early and late leak wasoccasionally difficult, and a ‘balanced judgment’ was made. Eliminationof these rather uncertain timings do not change the general pattern ofthe analysis.

Summary Analysis:

1) 8 pts leaked early with both VC and iRCT;

2) 20 pts leaked early with iRCT and late with VC;

3) 5 pts leaked early with VC and late with iRCT;

4) 14 pts leaked early with iRCT and not at all with VC.

5) 0 pts leaked early with VC and not at all with iRCT 123 pts leaked.42 pts leaked early with iRCT. 13 leaked early with VC.

Detailed Analysis: Patients Who Leaked with Both VC and iRCT and HadLate Leak Times for Both:

612-2, 567-1, 605-1, 701-1, 519-1, 520-1, 522-1, 518-1, 539-1, 543-1,551-1, 553-1, 562-1, 208-1, 303-1, 311-1, 315-1, 509-1, 511-1, 513-1,1202-2, 1207-1, 1112-1, 823-1, 927-1, 812-1, 917-1, 1202-1, 716-1,711-2, 1045-1, 1027-1

N=33

Patients Who Leaked with Both VC and iRCT and Had Early Leak Times forBoth:

569-1, 616-1, 1114-1, 802-1, 1035-1, 554-1, 1014-1, 1038-1

N=8

Patients Who Leaked with Both VC and iRCT and Had Late Leak Times for VCand Early Leak Times for iRCT:

568-1, 516-1, 544-1, 548-1, 555-1, 556-1, 560,1, 565-1, 313-1, 1017.1,1011-1, 1025-1, 314-1, 12041, 1205-1, 1117-1, 1108-1, 805-1, 809-1,1038-1

N=20

Patients Who Leaked with Both VC and iRCT and Had Early Leak Times forVC and Late Leak Times for iRCT:

1104-1, 1206-1, 934-1, 1001-2, 707-2

N=5

Patients Who Did not Leak with VC and Had Early Leak Times with iRCT:

540-1, 564-1, 567-1, 1203-2. 1102-1, 1106-1, 926-1, 921-1, 1021-1,1043-1, 1029-1, 1019-1, 1012-1, 713-1

N=14

Patients Who Did not Leak with VC and Had Late Leak Times with iRCT:

549-1, 559-1, 517-2, 606-1, 531-1, 535-1, 536-1, 537-1, 547-1, 550-1,552-1, 561-1, 510-1, 1208-1, 1119-1, 1120-1, 1107-1, 1111-1, 930-1,823-1, 804-1, 702-1, 1003-1, 712-1, 717-1, 718-1, 719-1, 708-1, 701-1,1040-1,1041-1, 1046-1, 1036-1, 1015-1, 1008-1, 1009-1, 1006-1, 1048-2N=38Patients Who Did not Leak with iRCT but Who Had Late Leak Times with VC:611-2, 530-1, 310-1, 505-1, 820-1N=5Patients Who Did not Leak with iRCT but Who Had Early Leak Times withVC:N=0Summary:

1) 123 pts were assessed. They all leaked with either VC or iRCT orboth. Thus potentially there could be 246 leaks. In fact there were 189since some pts did not leak on both tests.

2) 118 pts leaked with iRCT (96%); 71 leaked with VC (58%); 66 (54%)leaked with both.

3) 66 pts leaked with both VC and iRCT. 28 of them (42%) had early leaktimes for iRCT. 13 (20%) had early leak times for VC. (8, 12%, hadboth.) 33 pts (50%) had only late leak times.

4) 52 pts leaked only with iRCT; 14 (27%) had early leak times.

5) 5 pts leaked only with VC; none (0%) had an early leak.

FIGS. 21 and 22 are graphs showing urodynamic tracings of a test serieswith a forceful voluntary cough in a female subject. FIG. 21 shows theresults with the female subject who does not have a history of SUI. FIG.22 shows the results with the female subject who has moderate/severeSUI. The voluntary cough and involuntary cough reflex test are shown.The urinary bladder is filled with 200 milliliters of saline andintravesicle and rectal pressure catheters are used in this example. InFIG. 22, it shows that the voluntary cough did not elicit SUI despite aseries of vigorous individual consecutive inhalation voluntary coughefforts.

As noted before, voluntary cough (VC) and the laryngeal expiratoryreflex (LER) as elicited by an involuntary reflex cough test (iRCT),using a nebulized 20% tartaric acid solution, have distinctly differentneurophysiological mechanisms. Voluntary cough is classically defined asan event that starts with an inspiration that leads to lung inflation.As the lungs inflate during inspiration, there is a correspondingincrease in the tonicity of both the urethral sphincter (US) and loweresophageal sphincter (LES) (as shown in FIG. 21).

There is increased tonicity of the US and LES with lung inflation,Increased sphincter tonicity is a patterned motor event, whichfacilitates US and LES closure during increases in intra-abdominalpressure (IAP) that commonly occurs following lung inflation, i.e., theinspiratory phase of voluntary cough. The LER does not have asignificant lung inflation phase prior to the series of expiratorycoughs. As such, increased IAP can cause stress urinary incontinence(SUI) or gastroesophageal reflux (GER) to occur due to inadequateclosure of these sphincters in subjects who have Intrinsic SphincterDeficiency (ISD) (as shown in FIG. 22).

There now follows a description of what occurs as part of as part ofnormal lung inflation with inhalation as it relates to sphincterincreased tonicity and closure for both urethral (US) and loweresophageal sphincter (LES) before Voluntary Cough. The Hering-Breuerinflation reflex (H-B Reflex) cannot be activated with iRCT because lunginflation does not occur. Airway protection from a perceived stimulusthat could be perceived as life threatening by the body short circuitsall the reflexes that are connected to the H-B Reflex system by causingvocal cord closure in 14 msecs, and in about 20 msecs IAP elevationoccurs without the additional sphincter tonicity closure that wouldoccur reflexively with inhalation lung inflation.

The involuntary reflex cough test causes significant diaphragm elevationwith iRCT that does not occur with voluntary cough because the H-BReflex, in part, holds the diaphragm down with the closed LES, despitequite highly elevated intra-abdominal pressure. The diaphragm is notheld down with the iRCT, the diaphragm elevation actually pulls the LESup with it causing partial gastric content reflux. The reflux causes avicious cough/reflux cycle to occur that leads to insidious diseaseslike GERD, COPD, laryngitis, Barret's Esophagitis, heartburn and similarproblems. The same involuntary maneuver using the involuntary reflexcough test will diagnose SUI by blocking the inhalation tonicity thatwould possibly come from lung inflation via H-B Reflex.

The Hering-Breuer inflation reflex is a reflex triggered to preventoverinflation of the lungs. Pulmonary stretch receptors present in thesmooth muscle of the airways respond to excessive stretching of the lungduring large inspirations. Once activated, they send action potentialsthrough large myelinated fibers of the paired vagus nerves to theinspiratory area in the medulla and apneustic area of the pons. Inresponse, the inspiratory area is inhibited directly and the apneusticarea is inhibited from activating the inspiratory area. This inhibitsinspiration, allowing expiration to occur.

Josef Breuer and Ewald Hering reported in 1868 that a maintaineddistention of the lungs of anesthetized animals decreased the frequencyof the inspiratory effort or caused a transient apnea. The stimulus wastherefore pulmonary inflation.

The neural circuit that controls the Hering-Breuer inflation reflexinvolves several regions of the central nervous system, and both sensoryand motor components of the vagus nerve. Increased sensory activity ofthe pulmonary-stretch lung afferents (via the vagus nerve) results ininhibition of the central inspiratory drive and thus inhibition ofinspiration and initiation of expiration. The lung afferents also sendinhibitory projections to the cardiac vagal motor neurones (CVM) in thenucleus ambiguus (NA) and dorsal motor vagal nucleus (DMVN). The CVMs,which send motor fibers to the heart via the vagus nerve, areresponsible for tonic inhibitory control of heart rate. Thus, anincrease in pulmonary stretch receptor activity leads to inhibition ofthe CVMs and an elevation of heart rate (tachycardia). This is a normaloccurrence in healthy individuals and is known as sinus arrhythmia.

Early physiologists believed the reflex played a major role inestablishing the rate and depth of breathing in humans. While this maybe true for most animals, it is not the case for most adult humans atrest. However, the reflex may determine breathing rate and depth innewborns and in adult humans when tidal volume is more than 1 L, as whenexercising.

The Hering-Breuer deflation reflex serves to shorten exhalation when thelung is deflated. It is initiated either by stimulation of stretchreceptors or stimulation of propriocetors activated by lung deflation.Like the inflation reflex, impulses from these receptors travelafferently via the vagus. Unlike the inflation reflex, the afferentsterminate on inspiratory centers rather than the pontine apneusticcenter. These reflexes appear to play a more minor role in humans thanin non-human mammals.

FIG. 21 shows a graph for an urodynamic tracing of a series of tests anda forceful voluntary cough in a normal female subject with a urinarybladder filled with 200 ml of saline. There is no evidence of SUI, i.e.,urine leakage, during the series of voluntary cough or the five-cough(C5) iRCT stimulus. With the iRCT the episode can have an averageduration of 14.8 seconds and consists of an average of 5 expiratorycoughs, during which there is no significant inhalation or lunginflation to activate US and LES tonicity. This subject is continentwithout the facilitatory effect of increased tonicity associated withlung inflation.

FIG. 22 is a graph for an urodynamic tracing of a series of tests and aforceful voluntary cough in a female subject, who has moderate/severeSUI. Voluntary cough did not elicit urinary incontinence despite theseries of vigorous individual consecutive inhalation voluntary coughefforts. The iRCT caused immediate SUI with multiple leakages (linesindicated at 22 a) during the 26-second involuntary event.

The discrepancy between the voluntary cough and iRCT in demonstratingSUI is due to the facilitatory effect of increased tonicity associatedwith lung inflation in voluntary cough. The voluntary cough in FIG. 22had a similar robust peak IAP and much greater average IAP than the iRCTin this subject. The SUI was not a result from any differences in IAP orcough duration, but was secondary to the absence of the facilitatoryeffect of increased tonicity associated with lung inflation.

The laryngeal expiratory reflex (LER) is normally triggered when food,fluid or secretions enter the larynx during swallowing or inspiration.Reflex cough can be triggered by aspiration of food or fluid duringinspiration acid reflux stimulation of laryngeal receptors or post-nasaldrip into the larynx, laryngeal inflammation or infection. Although thestudies on gastroesophageal reflux (GER) claim that cough is a result ofgastric acid reflux, it is believed that involuntary cough is the directcause of GER and this may lead to a previously unrecognized cycle wherecough causes reflux that produces the cough associated with GER. Thisinfers that instead of treating the cough, steps should be clinicallytaken to reduce the reflux. SUI is primarily caused by cough. The typeof cough that causes SUI is an involuntary cough and not voluntarycough, thus, by decreasing stimuli exposure, i.e., reflux that cantrigger involuntary cough, SUI could be reduced. The more comprehensiveclinical approach using the involuntary maneuver, i.e., iRCT, willimprove the identification of both SUI and GER when they can still beeffectively and conservatively treated before the development ofsignificant comorbidities.

Intrinsic sphincter deficiency (ISD) may be clinically present as SUIand GER. The iRCT is clinically useful in improved evaluation of LESfunction and a more realistic assessment of SUI.

There now follows a description of a method that can be used forprocessing urodynamic data obtained during the iRCT and processed in thehandheld device in accordance with non-limiting examples. FIGS. 23-26are more detailed flowcharts showing this example of various steps thatcan be used for obtaining and processing data received from theinvoluntary reflex cough text (iRCT) for stress urinary incontinence.

The process starts (1000) with the involuntary reflex cough test andproceeds from this test. One activity that may be pre-involuntary reflexcough test is an ultrasound to determine the starting bladder volume. Itshould be understood that FIGS. 23 and 24 are representative for anoutpatient setting. In this outpatient example shown in FIGS. 23 and 24,it typically is about at least 200 ml starting. With the inpatientexample shown in FIGS. 25 and 26, the doctor or technician waits untilthe patient feels the urge to void and then performs the ultrasound tomeasure the starting volume. There are some reasons for the differences,but neither requires bladder filling initially.

As shown in FIGS. 23 and 24 for the outpatient example, the processstarts (1000) with the involuntary reflex cough test, also termed theinduced reflex cough test. A determination is made if the pad is leakedon (1002) and if yes, then the sequence shown in FIG. 24 for pad leakageis followed (1004). If not, a determination is made if the post-voidresidual is greater than 50 ml (1006). If not, a determination is madeif the detrusor pressure is normal (or elevated) (1008). Detrusorpressure is a difference between bladder and abdominal pressure and alsouses a catheter in the rectum. If yes, then there is normal physiology(1010) and no treatment (1012). If not, then a determination is madewhether the detrusor pressure is increased (1014) and if yes, then thereis possible detrusor instability or urge (1016). This could becontractions. A course of action is a time void for symptoms andpossible Diptropan if no urinary tract infection (UTI) is present(1018). If the detrusor pressure was not increased, and the detrusorpressure is less than zero, then any rectal catheter as used can bemoved or reinserted an amount greater than or equal to 15 centimetersand then retest (1020). For example, the abdominal pressure is readinghigher than the bladder pressure, obtaining a negative detrusor value.This could indicate that something is wrong and the catheter is notplaced correctly.

If the post-void residual is greater than 50 ml, then a determination ismade if the detrusor pressure is normal (1022). If yes, this couldsignify atonic bladder, detrusor hypotonia, or bladder outletobstruction (BOO) (1024). Urecholine can be considered and possiblepost-void residual (PVR) intermittent catheterization procedure (ICP) inwhich the catheter is placed in the patient to drain the bladder (1026).

If the detrusor pressure was not normal, then a determination is madewhether the detrusor pressure was increased (1028). If yes, this couldsignify an upper motor neuron bladder, stress or mixed urinaryincontinence, overflow urinary incontinence, possible urinary tractinfection, possible bladder outlet obstruction, and possible dyssynergia(1030). This can be followed by a urology evaluation and PVR/ICPcorresponding to a post-void residual and intermittent catheterizationprocedure (1032). The possible dyssynergia (1030) corresponds to bladdersphincter dyssynergia also termed detrusor sphincter dyssynergia (DSD)in some non-limiting examples as a neurological condition with acontraction of the bladder musculature as not coordinated with therelaxation of the sphincter. In some of these instances, instead of theurethra completely relaxing during voiding, it may dyssynergicallycontract causing the flow to be interrupted and the detrusor pressure torise. On systography, there is typically an irregular appearance of abladder outline because of musculature contraction against the unrelaxedbladder sphincter. Usually individuals with this type of condition mayhave daytime and night-time wetting and a history of urinary tractinfections (UTI).

If the detrusor pressure is not increased, then recatheterization canoccur if the detrusor pressure is less than zero and a rectal cathetercan be moved or reinserted greater or equal to about 15 centimeters andretested in this non-limiting example (1034).

In one of these outcomes, the atonic bladder typically corresponds to alarge dilated urinary bladder that does not empty, usually because ofthe disturbance of innervation or chronic obstruction. This couldrequire a primary caregiver or other medical professional to considerurecholine if there is no urinary tract infection (UTI) or BOO (such asin 1026). A possible PVR ICP could be considered. Urecholine, of course,is also termed bethanechol as a parasympathetomimetic choline ester thatstimulates the muscarinic receptors with further selectivity for M3receptors without any effect on nicotinic receptors.

Diptropan as a generic oxybutynin is typically used to reduce musclespasms of the bladder and urinary tract and treat symptoms of theoveractive bladder causing frequent or urgent urination, incontinence asurine leakage and increased night-time urination.

FIG. 24 shows the pad leakage (1004) sequence. A determination is madeif the post-void residual is greater than 50 ml if there was pad leakage(1004). If not, a determination is made if the detrusor pressure wasnormal (1042) and if yes, this indicates genuine stress urinaryincontinence (1044). As an outcome, urinary tract infection is ruled outand exercises can be described and medication such as Duloxetine andpossible surgery with tape or sling (1046). If the detrusor pressure isnot normal, a determination is made if the detrusor pressure wasincreased (1048) and if yes, this could indicate mixed incontinence andstress or urge incontinence (1050). As an outcome, there could be acombination treatment. Urinary tract infection is ruled-out and possibletime void (1052). If the detrusor pressure is not increased and theoutcome of testing is such that the detrusor pressure is less than zero,the rectal catheter can be reinserted greater than or equal to about 15centimeters and retesting occurs (1054).

If in these steps the post-void residual is greater than 50 ml, adetermination is made if the detrusor pressure is normal (1056). If yes,this could be a sign of atonic bladder, detrusor hypotonia, stressurinary incontinence or overflow urinary incontinence (1058). Again,urinary tract infection is ruled out and a possible PVR/ICP with a timevoid and possible urecholine (1060).

If the detrusor pressure was not normal, a determination is made if thedetrusor pressure was increased (1062), and if yes, this could signifyupper motor neuron bladder, stress or mixed urinary incontinence,overflow urinary incontinence, or possible dyssynergia (1064). Theoutcome is a PVR/ICP, the rule-out of UTI, possible diptropan, andpossible urological evaluation (1066). If the detrusor pressure was notincreased and is less than zero, an outcome is to move or reinsert therectal catheter, greater than or equal to about 15 centimeters andretest in a non-limiting example (1068).

FIGS. 25 and 26 show a flow sequence similar to that shown in FIGS. 24and 25, but in this example, the sequence is for inpatient testing. Theprocess starts (1070) and a determination is made whether the post-voidresidual is greater than 100 ml (1072). If yes, then a determination ismade whether the resting destrusor pressure is greater than 30centimeters of water (1074). If yes, this could correspond to the uppermotor neuron (UMN) bladder and detrusor/sphincter dyssynergia (1076). Atthis time, a urology evaluation can occur and ICP (intermittentcatheterization procedure). The clinician can consider a Foley catheterplacement. Urinary tract infection is ruled out and bladder outletobstruction (BOO) is ruled out (1078). If the detrusor pressure was notgreater than 30 centimeters of water at resting, then a determination ismade whether voiding and detrusor pressure was greater than 60 (1080).If not, this can signify the atonic bladder or hypotonic bladder (1082)and the outcome can be PVR/ICP and the UTI ruled out. If there is noUTI, then urecholine is considered (1084).

If the voiding and detrusor pressure is greater than 60, then adetermination is made whether the pad leaked (1086). If yes, this cancorrespond to bladder outlet obstruction and overflow incontinence(1088). Possible considerations can be the ICP, a Foley catheter, aurology evaluation. UTI is ruled out or prostate (PSA). The clinicianalso rules out bladder outlet obstruction, i.e., BPH or pelvic organprolapse (10%). If there is no pad leak, this could possibly correspondto bladder outlet obstruction (1092) and the same outcome processingoccurs (1090).

If the initial PVR was not greater than 100 ml, a determination is madeif the detrusor pressure was greater than 30 centimeters of water atrest (1094). If yes, this can correspond to detrusor instability, urgeincontinence and mixed incontinence (1096). UTI is ruled out andpossible Ditropan or Detrol is considered if there is no UTI. A stressurinary incontinence evaluation in urology is considered at this time(1098). If the detrusor pressure was not greater than 30 centimeters ofwater, then a determination is made whether the pad leaked (1100), andif yes, this step corresponds to stress urinary incontinence (1102) anda time void or urology evaluation considered (1104). If there is no padleakage, then a normal study is considered (1106).

FIG. 26 shows a preferred sequence of steps for inpatient processing ascompared to that sequence shown in FIG. 25. Some of the sequence stepsare similar as shown in FIG. 25. The process starts (1110) and adetermination is made if the post void residual is greater than 100 ml(1112). If yes, a determination is made if the resting detrusor pressureis greater than 15 centimeters of water (1114). In this example, if yes,it could signify UMN Bladder or DSD (1116). A urology evaluation occurs(1118) and an outcome considers ICP, Foley catheter placement, rulingout UTI, ruling out bladder outlet obstruction, possible PSA, ruling outbladder outlet obstruction as BPH or pelvic organ prolapse, andconsidering urology evaluation as indicated (1120). If the voidingdetrusor pressure was greater than 60 (1122), a determination is made ifthere was a pad leak (1124) and if yes, this could correspond to bladderoutlet obstruction, overflow incontinence or possible DSD (1126) and theoutcome is similar as before (1120). If there is no pad leakage, thiscan correspond to bladder outlet obstruction and possible DSD (1128) andthe same outcome (1120).

If the detrusor pressure was greater than 60 ml at voiding, adetermination is made if there is a pad leak (1130) and if yes, this cancorrespond to overflow incontinence and possible SUI (1132). The outcomecan be PVR/ICP, the rule out of UTI, and urecholine if no UTI (1134). Ifthere is no pad leakage, this can correspond to atonic bladder followedby hypotonic bladder consideration (1136). The outcome is as before(1134).

If the PVR was not greater than 100 ml (1112), a determination is madeif the detrusor pressure is greater than 15 centimeters of water atresting (1138) and if yes, this can correspond to detrusor instability,urge incontinence and mixed incontinence (1140). UTI is ruled out.Ditropan or detrol is considered if there is no UTI. An SUI evaluationfor urology is considered. Males can consider normal pressurehydrocephalus (NPH) (1142).

If the detrusor pressure was not greater than 15 centimeters of water atresting (1138), a determination is made whether there was a pad leak(1144) and if yes, this can correspond to SUI (1146) and the outcome canbe a time void and urology evaluation with the time void indicating howmuch time it takes to void (1148). If not, then a normal study occurs(1150).

As shown by the different considerations and outcomes in FIGS. 23-26,many different possible tests and diagnoses with potential outcomes arepossible and the sequence of steps takes the clinician through what ispossible. Typically, the data is input into the handheld device andprocessed with the different scenarios and outcome and an evaluationdisplayed on the handheld device.

FIG. 27 is a high-level block diagram of basic components for thehandheld device illustrated generally in this example at 1200, which inone non-limiting example, uses wireless technology to receive pressurereadings such as shown in FIG. 8. This example relative to FIG. 27 showsa wired connection. In this example for the handheld device 1200, thedevice includes two pressure inputs, for example, to receive Vikingconnector receptacles and connect to TDOC pressure sensors. Asillustrated, the inputs at pressure 1 and pressure 2 correspond to thetwo respective catheters as inputs through the pressure sensors PS1 andPS2 into a pressure converter circuit 1202, which transmits the pressuresignals to the onboard processor 1204 through various AD signal lines asindicated. The pressure converter circuit 1202 includes pressuremeasurement electronics such as shown in the schematic circuit diagramof FIG. 30 and described in greater detail below. The pressuremeasurements obtained through the pressure sensors PS1 and PS2 areconverted and forwarded to the processor 1204, which in one non-limitingexample, is a single board computer such as a Rabbit LP3500. Thepressure sensors PS1 and PS2 are in one non-limiting example TDOC-4030pressure sensors. The catheters used at inputs P1 and P2 correspond inone non-limiting example to TDOC-6F catheters. It should be understoodthat EMC signals are input through interface circuit 1206 into theprocessor 1204. Data that is processed is displayed using a display unit1208 such a display/keyboard/LED, for example a rabbit KDU.

It should be understood that the improved catheter as described belowFIG. 31 can be used. In one non-limiting example, the pressure convertercircuit 1202 is powered by two nine-volt batteries or in an alternativeembodiment by four AA batteries 1210. The batteries are connected to anon/off switch 1212. A programming connector 1214 and RS232 connector1216 are connected into the processor 1204 to allow programming of theprocessor with appropriate software and code as described before and forprocessing data related to the involuntary reflex cough test. Data canbe retrieved or input. This device 1200 accomplishes both SUI andneuroanalysis using the appropriate data analysis.

FIGS. 28A-28D are respective plan, front elevation and side elevationviews of a housing 1220 that can incorporate the various systemcomponents such as shown in FIG. 27 and form the handheld device asdescribed before. The left side elevation view in FIG. 20C showsopenings 1222 for receiving Viking connector receptacles that connect toTDOC pressure sensors for the two catheters in this non-limitingexample. Of course, during handheld device use, only one catheter has tobe used as noted before and is some instances only EMC.

FIG. 28B shows the front elevation view with a programming connectoropening 1224 for a nine pin D male connection and the RS232 connectoropening 1226 for a nine pin D female in one non-limiting example. Theplan view shows enough space and volume to include switch and pressuresensor wiring 1228 and a single board computer 1230 and custom pressuresensor card as described below. The side elevation view and plan viewshow various battery holder areas 1232 for either a 2.9 volt or a fourAA battery holder.

FIG. 29 is a top plan view of the housing 1220 for the handheld deviceand showing a location for a power on/off toggle switch 1234 and adisplay with a keyboard and light emitting diodes (LED's) 1236.Non-limiting examples for possible dimensions for the handheld deviceare about 8 inches (x) and 5 inches (y).

FIG. 30 is a schematic circuit diagram of the pressure converter 1252 inaccordance with a non-limiting example and showing the various pressuresensor 1 input 1240 and pressure sensor 2 input 1242. These areindependent channels each with comparators and operational amplifiersillustrated generally at 1244 and 1246 respectively. These componentsand circuits connect into appropriate pin headers 1248 and 1250 thatoutput to a single board computer in this non-limiting example.

These examples show use of the pressure sensor as a TDOC-4030 pressuresensor and a catheter as a TDOC-7F (7 French) catheter. The catheter asdescribed below relative to FIG. 31 can be used in a non-limitingexample for the measurement.

Different processors 1204 as a single board computer can be used in anon-limiting example. The described Rabbit microprocessor is alow-power, single-board computer and is especially operable withportable handheld, battery-powered, remote monitoring systems. Itincludes built-in analog and digital input/output and typically consumesless than 20 milliamperes when operational and less than 100 microampsin a power-save mode. In this non-limiting example, it includes flashmemory and SRAM and various inputs/outputs and in one non-limitingexample eight analog/digital converter inputs with programmable gain andsix serial ports. It has pulse width modulation (PWM) outputs. It can beprogrammed using C software in a non-limiting example.

It should be understood that the display unit 1208 as illustrated inFIG. 27 is a separate display unit that includes the display, keyboardand light emitting diodes and supported on the housing, but could beincorporated integral with the single board computer in a non-limitingexample.

FIG. 31 is an example catheter 1300 that can be used in accordance witha non-limiting example. It is a urodynamic dual lumen catheter formedfrom a catheter body as an elongated tube with proximal and distal endsand preferably has a smallest external diameter that can contain twolumens within it. It is typically approximately 50 to about 60centimeters in length. A first lumen 1302 is used for monitoring bladderactivity. In one non-limiting example, it contains a stylet/wire sensorthat can be left within the lumen or used alone. A second lumen 1304permits the filling port to instill fluid into the urinary bladder. Thesecond lumen output is shown at 1306 and a sensor 1308 is positioned atthe distal end. This catheter includes a luer lock end for rapidconnection to infusion tubing or a syringe, and can accommodate rates ofinfusion up to 1,200 ml/hr via gravity flow or 15 ml/sec via manualinstallation. The external surface of the catheter has a surface areathat contains areas of indicators along its length shown generally at1310 that operate as a urine leak detect device. These indicators 1310change color when exposed to two components in combination in accordancewith a non-limiting example. This color change can occur with atemperature about 30 degrees Celsius and the presence of urea in anon-limiting example.

The catheter 1300 is used to evaluate bladder pressures at rest, emptyor with urine, filling with fluid during voiding. It is used to evaluatefor urinary incontinence by detecting a minimal amount of urine lossduring voluntary and involuntary maneuvers of the type as describedbefore. The stylet sensor in one non-limiting example is used alone forpressure monitoring while presenting the least amount ofdisruption/distortion of the urethra and urinary sphincters. The styletin another non-limiting example is packaged separately and inserted intoan existing Foley catheter to measure pressure and function in onenon-limiting example.

In one non-limiting example, the catheter is a dual lumen six Frenchcatheter of about 50 centimeters and includes the sensor 1308 and fillport at the second lumen 1304. It is inserted in a non-limiting exampleabout 10 centimeters for a female bladder and 15 centimeters for a malebladder. The location of color change indicators 1310 for a female couldbe about 11-14 centimeters, and for a male, about 16-19 centimeters. Inone non-limiting example, the urine pH range is about 4.6 to about 8.

It should be understood that the catheter is preferably a smallerdiameter catheter and includes those down to 3 (three) and 4 (four)French. The smallest catheter possible is used as a urethra catheter andsomewhat smaller than a standard ten (10) French catheter. It has beenfound that some patients have a tendency to leak with the largercatheter in place because of the size of the catheter or they becomeobstructed with that catheter in place. Smaller urinary bladdercatheters are typically about 6 (six) French and used for neonatalinfants. There are some PICC catheters (Peripherally Inserted CentralCatheters) that are three (3) and four (4) French. These smallercatheters should be double lumen in this example. This system is notlimited in size, but the smaller is advantageous.

The double lumen catheter, in accordance with a non-limiting example asdescribed, has the first lumen 1302 for a sensor probe 1308 and a secondlumen 1304 for the filling with liquid. The sensor probe is a “T-doc” asused with an air-charged catheter for pressure sensing and air-chargedpressure recording in one non-limiting example. It should be understoodthat this catheter can be used with or without filling the bladder, andadvantageously used in urodynamic testing. The doctor, nurse orclinician does not have to personally bend down and view the urethraarea to determine if there is leakage, which is an advantage in aclinical test. Different types of indicators 1310 as chemical indicatorscan be used.

In another non-limiting example such as shown in FIG. 32, the catheterincludes a support ring 1320 such as a silastic ring that holds aurine-indicating pad or other enzymatic pad 1322 and is affixed to thecatheter as a single unit wherein the catheter that measures theintravesicular pressure. The silastic ring 1320 carries a color changingpad in this example instead of using color indicators 1310 positionedalong the catheter surface as in the example of FIG. 31. This alsoprovides for a urinary leakage indicator. The support ring 1320 slideson the catheter in one example. It is permanently affixed to thecatheter, but adjustable in this example. A moisture indicating dye isused in an example on the pad 1322 positioned on the ring 1320. Anexample of a dye is disclosed in U.S. Pat. No. 4,327,731 as a moistureindicator, and in one aspect could be an enzyme catalyst.

Different types of pads or substrates could be used in combination withthe support ring 1320 and moveable along the catheter. This combinationcatheter and the urine indicating sensor, in one example, are specificfor use to determine an instance of stress urinary incontinence. It ispossible, however, to add a balloon to this catheter similar to a Foleycatheter such that the catheter remains in place. Two catheters are thuspossible. For example, a specific catheter and urine indicator are usedfor stress urinary incontinence. It is also possible to add a balloonwith the larger 14, 16, 18 or 20 French catheters as a larger size. Asensing system is included in this example. Added to this catheter is achannel for urine drainage, the sensor, and an indwelling balloon tokeep it in place. The catheter, in one example, is used to determinewhether the patient can protect their airway in conjunction with theinvoluntary reflex cough test (iRCT).

The cloth or pad 1322 is attached to the support ring 1320 and includeson the pad a regent that is permanently attached. It can be a single usecatheter for stress urinary incontinence (SUI) testing. It is includedwithin the test kit to be described in one example and includes thenebulizer (and the drug) for involuntary reflex cough testing asdescribed before.

In one example, it is possible to have a catheter of about three (3),four (4), or five (5) or somewhat larger French that thread inside aregular Foley catheter with pressure measurement capability. Thecatheter that goes inside the urethra, such as a seven (7) Frenchcatheter, can go inside a Foley catheter. In one example, the balloon ispart of the smaller catheter and measures or tests for airway protectionin the technique as described before.

An enzymatic moisture detector can be used. Initially, any indicators orpad and ring could be covered before catheter use. When needed, thecatheter is uncovered and moved into the proper position against themeatus. A first catheter is used with stress urinary incontinence andtesting. Another catheter as a second or larger diameter catheter isballoon specific for reflex cough testing to measure intra-abdominalpressure in determination of airway protection.

In an example, temperature is used with the sensor and changes thesensor as an indicator. It is possible to use the presence of urea forsensing urine. One problem is in bladder testing. The bladder is oftenfilled with saline water or other fluid that is not urine. If theindicator is specific to ammonia or urea, then it would not indicateadequately. Temperature is one advantageous solution and a material thatis sensitive to temperature change of about 90 degrees is adequate. Thefluid is inserted into the bladder and becomes warmer than roomtemperature. If there is leakage, it changes the color of the cathetereven without the presence of urea.

The tip of the catheter can be placed into the urethra and the outsideof the catheter includes the indicator. It changes color if there isleakage whether there is urine inside the bladder or just fill. It couldchange the color of liquid after it leaks. This could be an assuranceagainst false positives such as would occur with perspiration from thedoctor's or nurse's hands. If there is a second testing such as insurgery (and the patient hopefully fixed), a different color could beused. In SUI testing, the liquid is placed in the bladder in oneexample, but would come out a different color when it reacts with thesensor on the bladder near the meatus. This assures that one is viewinga leakage and not a false positive.

There is a possibility for measuring airway using the port incombination. The catheter can be small enough to go into a side port ofa Foley catheter similar to a guide wire. Thus it is possible to takethe catheter out if it is obstructing in some way and leave a guidewire. It is possible to remove the catheter and still have a guide wireor small catheter that has a sensor probe on the end. Instead of havinga dual channel and having a tube inside a tube that you could do a fillaround, it is possible to remove the outside tube that is blocking theurethra. It should be understood that the catheter (depending on sizeand pathophysiology of a patient) can either block the urethra or holdthe urethra open, causing additional leakage. Specific catheter designsas described alleviate these problems. With the larger catheters, thelarger catheter size is used to fill and is taken out. The inside tube(catheter) stays. A smaller four (4) French catheter has a dual channel,one for the pressure sensor and the other to fill 1200 millimeters anhour and is adequate to cover different possibilities.

FIG. 33 shows an embodiment of a color changing urinary pad 1204 thatcan be used with a catheter such as described before. The color changingurinary incontinence pad 1400 is used in conjunction with a catheter1402 and has a small relief cut-out (hole) 1404 in the middle of the padwhere the catheter enters. The pad is placed against the underside nearthe urethra of a female typically and the catheter enters the urethraand extends through the hole in the center of the urinary incontinencepad for fluid flow and testing purposes. The pad could be taped to theunderside in the crotch area. For example, when the involuntary reflexcough test is given and the catheter is inserted through the urethra,the patient is prone to leak urine in some examples. This pad includesconcentric rings 1408 around the center catheter cut-out at preferred 10millimeter intervals for a target area of 50 millimeters. In onenon-limiting example, a nitrogen-ammonia (NH3) region is used toidentify positively the presence of urine on the pad. The targetintervals of 10 millimeters each are used to determine how much leakageand incontinence occurs during, for example, a reflex or involuntarycough test as described before. The different concentric areas havedifferent amounts of reagent in a non-limiting example or differentreagents to allow different color changes at the spaced intervalsdepending on the amount of urine leakage.

FIGS. 34 and 35 show example kits that can be used in accordance with anon-limiting example. A first kit 1500 shown in FIG. 34 includes apackage or housing 1502 or other housing that holds the kit component. Anebulizer 1504 includes the drug for the tartaric acid and a urinaryincontinence pad 1506 and an EMG pad 1508 to be placed at paraspinal. Asecond kit 1510 is shown in FIG. 35 and includes the nebulizer 1512 anda catheter 1514 such as described relative to FIG. 31, althoughdifferent types of catheters can be used. An EMG pad 1516 isillustrated. The kits are contained in self-contained housings orpackages 1502 with a quick-release. The various components as describedare throw away components, except the processing device. The kit couldinclude any necessary connector leads that connect into the handhelddevice.

Any catheter could include a wireless sensing device 1530 that isincluded in the kit in case wireless technology is used. Although awireless sensing device could be separately connected to the catheterafter the kit is opened, in one aspect, it is possible to include thewireless sensing device connected to any appropriate catheter such thatthe kit is open, the nebulizer removed, any pad and the catheter withwireless sensing device. The handheld device can be a separate deviceand the catheter used and wireless signals sent to the handheld device.After analysis and testing on a patient, the kit components such as thecatheter and wireless sensing device, pads and nebulizer could bedisposed of in the proper manner. It is possible that the EMG pads couldconnect into the wireless sensing device such that wireless signals aretransmitted to the handheld device that includes the pressure readingsand the EMG signals. Thus, the kit or system when removed would includethe pressure sensing device with the attached leads and EMG pad andcatheter that may be integrated together or separately removed and thenconnected to each other.

FIGS. 36-38 are flowcharts for the top level functions for processingthat can occur in the handheld device as described relative to FIGS.4-8, 27-30 and 39-42. The different functional menu options in FIG. 36after initialization include calibrate (1); running the involuntaryreflex cough test (2); and transferring data (3) as illustrated with thenumbered alternatives that are input as a menu selection, followed byExit (4). FIG. 37 shows the sequence for the running of the involuntaryreflex cough test (iRCT) and the performing of the analysis algorithmcorresponding to FIGS. 23-26. FIG. 38 illustrates a sequence that can beused for the transfer of data.

Calibration as shown in FIG. 36 typically includes the measuring andstoring of the single ended inputs and the measuring and storing of thedifferential inputs. Running the involuntary reflex cough test begins asshown in FIG. 37 in which continuous pressure measurements are startedand all values stored. The display on the handheld unit typically willshow “Scan For Resting Bladder Volume” (RBV). The RBV is input into thedevice, which then displays “Place Catheter and Pad,” indicating thatthe clinician, nurse or doctor should place the catheter and pad at theproper location such as an EMG pad and urinary or other catheter asdescribed before. The resting detrusor pressure is calculated, and theinvoluntary reflex cough test is administered. The start and stop of theinvoluntary reflex cough test cough epoch is calculated, and continuouspressure measurements are stopped. The intra-abdominal pressure (IAP)results, the peak, the average, and the area under the curve (AUC) arecalculated. In an example, the display will state “Check for Leakage” todetermine if there has been urine leakage. The user of the handhelddevice would then input “Leak” or “No Leak” as an option at the handhelddevice and the display would state “Scan For Post Void Residual” (PVR).The PVR is input and the analysis algorithm corresponding to thealgorithm described relative to FIGS. 23-26 is run. The iRCT results arethen displayed on the handheld device.

At this time, data can be transferred as explained in the sequence ofFIG. 38, in which the device display would recite “Connect Device toComputer” as a non-limiting example, indicating that a wireless or wiredconnection can be made to a computer for further processing. Thetransfer is initiated and any patient information, such as all measuredIAP, calculated parameters and analysis results are transferred.

Circuit components for the handheld device as an example are nowdescribed with further enhancements. The block diagram and schematiccircuit diagram of FIGS. 39 and 40 are similar to the block diagram andschematic circuit diagram of FIGS. 27 and 30 for the handheld device,but instead there is now shown a four channel system in which not onlypressure for P1 and P2 are measured, but also measurements are taken forEMG (EMG1) and pH (PH1) such as for reflux measurement, using the deviceand catheters as will be described relative to FIGS. 51-53. Similarreference numerals are used in this description of components in FIGS.39 and 40 as used with FIGS. 27 and 30, although the interface 120 bshows a general input reference, which could be another EMG, pressure,pH, or other similar input, including a spare channel.

FIGS. 41 and 42 show a six channel system in which three pH inputs areillustrated, for example, for measuring pH, for example, when pH probesare situated on a device (FIGS. 51-53) and pH probes or sensors arelocated in the stomach, at the lower esophageal sphincter (LES),mid-esophageal area, and/or superior esophageal area. It should beunderstood that an eight channel system can also be used in which theremay be four pH channels for the four locations as described, twopressure channels and two EMG channels. One of the channels, in thealternative, could be a spare channel. The particular choice of channelsis a choice of one skilled in the art and what is being analyzed.

In an example, the EMG sensor circuit could incorporate a DELSYS DE-2.1and the pH measurement probe could incorporate a MediPlus 25100 asnon-limiting examples. The pressure sensor could be a TDOC-4030 for PS1and PS2 and the catheter function as P1 and P2 could be a TDOC-7F.

There now follows an example of a pseudocode, which explains in a morecogent manner the function of the programming code that could be usedwith the handheld device as described in accordance with a non-limitingexample:

/******************************************************************************Function : Init_Arrays Description : Initializes all the arrays topredefined values deemed as having no valid meaning.******************************************************************************/Init_Arrays( ) While (index <NUM_ENTRIES)  VesicularPressure[index]=UNDEF_PRESSURE AbdominalPressure [index]= UNDEF_PRESSUREDetrusorPressure [index] = UNDEF_PRESSURE index = index + 1 End WhileEnd // Init_Arrays/******************************************************************************Function : Calculate_Pdet_Array Description : Calculates theDetrusorPressure values throughout the cough event and populates thearray accordingly.******************************************************************************/Calculate_Pdet_Array( ) index = CoughStart While (index <=CoughStop)DetrusorPressure [index]= VesicularPressure [index] − AbdominalPressure[index] index = index + 1 End While End // Calculate_Pdet_Array/******************************************************************************Function : Normalize_Event_Array Description : Normalizes the Pves forthe duration of the cough event only, by subtracting the baselinepressure from every Pves value.******************************************************************************/Normalize_Event_Array( ) index = CoughStart While (index <=CoughStop)VesicularPressure [index]= VesicularPressure [index] − BaseLinePressureindex = index + 1 End while End // Normalize_Event_Array/******************************************************************************Function : Average_Pressure Description : Calculates the average valueof an array subset.******************************************************************************/Average_Pressure( ) Sum = 0; index = CoughStart While (index<=CoughStop) Sum = Sum + VesicularPressure [index] index = index + 1 EndWhile AveragePressure = Sum/( CoughStop − CoughStart + 1) End //Average_Pressure/******************************************************************************Function : Peak_Pressure Description : Finds the peak value of an arraysubset.******************************************************************************/Peak_Pressure( ) PeakPressure = UNDEF_PRESSURE index = CoughStart While(index <=CoughStop) If (VesicularPressure [index]>= PeakPressure)PeakPressure = VesicularPressure [index] End If index = index + 1 EndWhile End // Peak_Pressure/******************************************************************************Function : Find_Level_Pressure Description : Searches a subset of thepressure array for a window where the pressure is “relatively” level.******************************************************************************/Find_Level_Pressure( ) index = 0 While (index < NUM_ENTRIES) CalculateSlope between VesicularPressure [index] and VesicularPressure [index+1]If (Slope < SlopeTolerance) If (Duration > XTime) ) Stop = index−1Escape While End If End if index = index + 1 End While End //Find_Level_Pressure/******************************************************************************Function : Event_Start Description : Determines the start point for acough event by examining the slope between consecutive points.******************************************************************************/Event_Start( ) index = 0  While (index < NUM_ENTRIES) Calculate Slopebetween VesicularPressure [index] and VesicularPressure [index+1] If(Slope > SlopeTolerance) If (Count > ConsecutiveTimes) Start = indexEscape While End If Count = Count + 1 End if index = index + 1  EndWhile End // Event_Start/******************************************************************************Function : Event_End Description : Determines the end point for a coughevent by examining the slope and determining if the pressure hasremained relatively unchanged for a certain length of time.******************************************************************************/Event_End( ) Stop = Find_Level_Pressure( ) End // Event_End/******************************************************************************Function : Boundarize_Event Description : Determines the start and endpoints for a cough event.******************************************************************************/Boundarize_Event( ) CoughStart = Event_Start( ) CoughStop = Event_End( )End // Boundarize_Event/******************************************************************************Function : Baseline_Pressure Description : Determines the baselinepressure for a cough event by looking for a relatively flat pressure forat least a 2 second window prior to the cough event.******************************************************************************/Baseline_Pressure( ) Start = 0; Average = Average_Pressure( ) Stop =Find_Level_Pressure(Average) If (Stop > (Start + 2 seconds)) Start =Stop − 2 seconds End If BaseLinePressure = Average_Pressure (Start,Stop)End // Baseline_Pressure/******************************************************************************Function : Calibrate Description : Allow the user to calibrate thepressure sensors. If voltage levels are too low the program will exit.******************************************************************************/Calibrate( ) Voltage = ReadAnalogVolts( ) If (Voltage < 14.0)Display(“Please replace 9V batteries!”) Exit Program Else If (Voltage >=14.0) Voltage = ReadAnalogVolts( ) If (Voltage < 6.0) { Display(“Pleasereplace AA batteries!”} Exit Program End If Display {“Connect pressuresensors and place in OPEN position.”) Vp1cal = ReadAnalogDiff(Channel0)Vp2cal = ReadAnalogDiff (Channel2) Display (“Unit calibrated. Close bothpressure sensors.”) End If End // Calibrate/******************************************************************************Function : In_Patient_Physiology Description : Performs the inpatientphysiology algorithm.******************************************************************************/In_Patient_Physiology(void) If (PostVoidResidual > 100.00) If(RestingDetrusorPressure > 15.00) dispLedOut(RED) // UMN Bladder //Detrusor/sphincter dyssynergia (DSD) // UROLOGY EVAL Else If(RestingDetrusorPressure <= 15.00) If (MaxVoidingDetrusorPressure >60.00) If (PatientLeaked) dispLedOut(YELLOW) // Bladder OutletObstruction (BOO) // Overflow incontinence // Possible DSD ElsedispLedOut (YELLOW) // Bladder Outlet Obstruction (BOO) // Possible DSDEnd If Else If (MaxVoidingDetrusorPressure <= 60.00) If (PatientLeaked)dispLedOut(YELLOW) // Overflow incontinence // Possible SUI ElsedispLedOut(YELLOW) // Atonic bladder // Hypotonic bladder End If End IfEnd If Else If (PostVoidResidual <= 100.00) If(RestingDetrusorPressure > 15.00) dispLedOut(YELLOW) // Detrusorinstability // Urge incontinence // Mixed incontinence Else If(RestingDetrusorPressure <= 15.00) If (PatientLeaked) dispLedOut(YELLOW)// SUI Else dispLedOut(GREEN) // Normal Study End If End If End If End// In_Patient_Physiology/******************************************************************************Function : Run_RCT_Test Description : Performs the steps to run the RCTtest.******************************************************************************/Run_RCT_Test( ) RestingBladderVolume = SetBladderVolume(“Please scan andenter RBV: ”) Display (“Please place the catheter) Display (“Pleaseplace the pad”)  Start measuring to establish baseline andDetrusorPressure Calculate Resting DetrusorPressure for 30 secondsDisplay (“Please perform iRCT test) PostVoidResidual =SetBladderVolume(“Please scan and enter PVR: ”) PatientLeaked =VerifyLeak(“Did patient leak (Y/N)?”) Stop measuring pressuresBaseline_Pressure( ) Boundarize_Event( ) PeakPressure = Peak_Pressure( )Average = Average_Pressure( ) Calculate AreaUnderCurveIn_Patient_Physiology( ) Display ( PeakPressure , Average,AreaUnderCurve) End // Run_RCT_Test//------------------------------------------------------------------------// Main program runs the display with menu.//------------------------------------------------------------------------main ( ) Initialize all hardware and parameters Init_Arrays( ); while(Not Exit)  Get MenuOption from the user If (MenuOption = 1) Calibrate() Else If (MenuOption = 2) Run_RCT_Test( ) Else If (MenuOption = 3) Download measured and calculated data Else If (MenuOption = 4) ExitProgram End If End While End // main

FIGS. 43 and 44 are graphs illustrating a subject that had a neurodecline over about a 1.5 year period. There is a marked decline in theiRCT measured variables and it is used to help determine medicalmanagement and demonstrate to the patient objective data to help inexplaining the patient's physical condition and neurological status.Both tests are about the same for the costs and duration, but have adrastic decline in variables for airway protection (peak, average IAPand AUC). This patient had been fed by a stomach tube, PercutaneousEndoscopic Gastrostomy (PEG), which he chose in order to try to prolongrespiratory health. The patient had been discharged home with apermanent stomach PEG and oral hygiene, but nothing significant by mouthand the patient had agreed. The patient had been diagnosed as havingParkinson's Disease, but it appeared to be Amyotrophic Lateral Sclerosis(ALS) and the patient was completely capacitated and had no otherParkinson's symptoms. Sinemet and Eldapril were not effective. This didnot change the recommendations or description of the risk to thepatient. The patient was to be followed up with pulmonary analysis withadditional oxygen as needed for exertion only.

FIGS. 45-47 are graphs showing a CMG summary with the iRCT (FIG. 45) andthe four-channel Cystometry (CMG) (FIG. 46) and the Electromyography(EMG) from the L5/S1 midline paraspinal muscles for a subject. The eventlasts seven seconds. This is a normal iRCT/LER test. FIG. 47 shows thegraph for dual external abdominal oblique (EAO) muscles. The graphsappear symmetrical and synchronous. The left side is apparent by EKG andthis artifact could be reduced in later studies by filtering, but it isclear evidence of R (Right) versus L (Left) external abdominal oblique(EAO) muscle activation by LER. This subject is profoundly aphasic,non-agitated, has a PEG tube, Left MCA CVA (middle cerebral artery,cerebrovascular accident) with dense R hemiparesis and neglect. Thesubject is unable to perform voluntary cough or follow-up commands.There is mild increased R tone and brisk reflexes present. Bilateralismand decussating pathways of LER are at brainstem level in the subjectwithout evidence of brainstem shock. The IAP are truncated, but themachine reads greater than 1,000 cm/H2O pressure. No adverse events wereseen and the patient tolerated easily. It is apparent that the EAO EMGis not necessary and the IAP reflects function well. This can becompared easily to another patient as shown in FIG. 48 for an aphasicsubject with the absent iRCT.

FIG. 48 is a graph showing an abnormal LER iRCT as compared to thenormal LER iRCT as shown in the previous graphs of FIGS. 45-47. Thesedemonstrate the differences between normal and abnormal with themeasurement. It is evident there is a response present based on EMG fromthe L5/S1 and small corresponding pressure changes so even though theevent is abnormal, it is still defined by the systematic approach asdescribed. This shows that there is a decline or recovery by measurementand how this information is used can determine treatment and managementchoices.

There now follows details for NG/OG devices in FIGS. 51-53, which can beused to diagnose GERD, treat reflux, protect a patient's airway, andperform analysis as associated with the iRCT as explained below.

Aspiration pneumonia is a leading cause of morbidity and mortality inneurological compromised patients. Stroke associated pneumonia,occurring in 7-22% of patients, is a major complication and thought tobe the most common cause of poor outcome and death in stroke patients.The risk for pneumonia is highest in the acute state of stroke and inpatients with non-lacunar strokes in the middle cerebral artery (MCA)territory. Several risk factors contribute to the increasedsusceptibility of stroke patients for infections: aspiration due todrowsiness, impaired bulbar reflexes, dysphagia, hypostasis inbed-ridden patients, and a requirement for invasive medical procedures.Previous studies have found dysphagia is associated with respiratoryinfections, but those patients who are NPO (nothing by mouth) and tubefed have a higher risk of developing infections due to aspiration ofbacteria-laden saliva or refluxed material than stroke patients who arefed orally.

“Nothing by mouth” tube-fed survivors were unlikely to have aspiratedanything other than saliva/secretions or reflux, but they hadsignificantly higher rates of respiratory infections than thosesurvivors fed orally. Stringent oral care and measures to prevent refluxare potentially modifiable aspects of stroke management.

It is estimated that up to 38% of patients die one month within theonset of acute stroke. Pneumonia contributes to 34% of all stroke deathsand represents the third cause of mortality in the first month afterstroke. After stroke or other neurologic events, the laryngeal coughreflex (LCR) may be weakened or absent. This increases the risk ofaspiration of food, medications, fluids or secretions past the vocalcords, leading to the development of pneumonia. Overall mortalityassociated with large volume gastric aspiration is approximately 30%. Itis greater than 50% in patients with shock, secondary infectiouspneumonia or ARDS (adult respiratory distress syndrome).

There now follows details of a device that can be used for iRCTdiagnosis, prevent reflux, and protect a patient's airway as an NG/OG(Nasogastric/Orogastric) device.

The device shown in FIGS. 51 a-51 e can be used with the system andmethod as described above to prevent reflux, protect a patient's airway,and analyze a patient using the iRCT. It is well known that Salem sumpsare typically clear-and-blue tubes that are two tubes in one. Salemsumps overcome the disadvantages of the older single lumen nasogastric(NG) tubes where if suction was applied and the stomach drained, but thestomach was empty, the tube would suck up against the stomach wall orsuck air out of the stomach and collapse the stomach. Thus, the secondlumen as a “blue” tube is typically added such that when the stomach isempty, the second tube allows air to come back into the stomach andprevent the tube from sucking up against the stomach wall and allowventing such as for belching. This is the “sump” as the second lumen andsometimes referred to as the “pigtail” to allow venting.

FIG. 49 shows a flowchart of the various treatment possibilities forischemic stroke patients. A few deaths occurred, but the survivors hadto be either tube fed or fed orally. In this example, the flowchartshows an example of one study and the percentage of infections and noinfections and the type of respiratory or other infections thatoccurred. Other studies would vary of course from those results. FIG. 50shows time-to-infection data for survivors who are tube fed and developinfections after stroke. FIGS. 49 and 50 thus illustrate the importanceof being able to attend to stroke patients.

FIGS. 51 a-51 e show the NG/OG device in accordance with non-limitingexamples. As will be explained in detail below, this device includes afoam or air-filled esophageal cuff that is inflated using a separatelumen that is separate from the main lumen and any sump lumen. Thedevice typically includes a pressure “bubble” at the end of theinflation lumen and could include a manometer connected for measuringpressure, for example, at the esophageal cuff and against the esophagealwall. Another lumen extending through the main body could be includedwith holes for suction just above the Lower Esophageal Sphincter (LES)to aid in suctioning reflux or emesis. This is advantageous for asurgery patient or acute neural or trauma patient. Details of suchdevice are explained below.

It should be understood that stroke can cause Lower Esophageal Sphincter(LES) weakness. The urology studies discussed above address thatdetermination. The LES is weakened by stroke and other factors,including the initiation of an involuntary cough such as through theiRCT test. The NG/OG device, in accordance with a non-limiting exampleand described in detail below, acts as an esophageal reflux protectiondevice to protect the patient from the weakness of the Lower EsophagealSphincter (LES). It is known that cough causes reflux, which causes morecough. This is a vicious cycle. This device allows blocking of emesisand prevents reflux associated with pneumonia and anesthesia or otherfunctions affecting neural patients. The NG/OG device shown in FIGS. 51a-51 e can be used when there is microscopic reflux or massive emesis,which both can cause pneumonia. In some instances, it may be possible touse a Foley catheter and a smaller catheter tube and the Foley catheterleft in place and a smaller catheter pulled after cough is measured.

It should be understood that the esophagus is about 25 centimeters long.It is a muscular tube with a diameter of about 2 centimeters average. Ittracks the vertebral column curve and descends through the neck andposterior medistinum and passes through the esophageal hiatus in theright crus of the diaphragm to the left of the median plane at the levelof the T10 vertebrae.

The esophagus enters the stomach at the cardial orifice to the left ofthe midline at the level of the 7th left costal cartilage and T11vertebra. The abdominal part of the esophagus extends from theesophageal hiatusis in the right crus of the diaphragm to the cardial(cardiac) orifice of the stomach. This area is only about 1.25 cm long.

Food passes through the esophagus rapidly because of the peristalticaction and is typically not dependent on gravity. The esophagus isattached to the margins of the esophageal hiatus in the diaphragm by thephrenicoesophageal ligament, an extension of the inferior diaphragmaticfascia. This ligament permits independent movement of the diaphragm andesophagus during respiration and swallowing. The esophagogastricjunction lies to the left of the T11 vertebra on the horizontal planethat passes through the tip of the xiphoid process. Immediately superiorto the esophagogastric junction, the diaphragmatic musculature formingthe esophageal hiatus functions as a physiological inferior (lower)esophageal sphincter (LES) that contracts and relaxes. The sphinctermechanism for the LES is typically efficient in preventing reflux ofgastric contents into the esophagus based on radiological studies. Thelumen of the esophagus is normally collapsed superior to this level toprevent food or stomach juices from regurgitating into the esophaguswhen an individual is not eating.

Barium fluoroscopic studies of the esophagus normally show threeconstrictions of the esophageal lumen due to impressions from adjacentstructures. These are possible locations for placing a device refluxanalysis and GERD treatment.

A first constriction is the cervical constriction (upper esophagealsphincter). The superior aspect of the esophagus is thepharyngoesophageal junction, and is approximately 15 cm from the incisorteeth. The cricopharyngeus muscle creates this cervical constriction,which is located at approximately the level of the sixth cervicalvertebra.

A second constriction is the thoracic (broncho-aortic) constriction. Thearch of the aorta and the left main bronchus cross the esophagus andcreate esophageal constrictions as seen on anteroposterior and lateralviews, respectively. The constriction caused by the arch of the aorta is22.5 cm from the incisor teeth and the constriction formed by the leftmain bronchus is 27.5 cm from the incisor teeth.

A third constriction is the diaphragmatic constriction. The esophagealhiatus of the diaphragm is approximately 40 cm from the incisor teethand forms the diaphragmatic constriction. This is at the level of thelower esophageal sphincter.

The presence of these constrictions is important when placing the deviceas described with the esophageal cuff, which would help prevent thereflux of gastric contents into the upper esophagus and pharynx. Theplacement of the device in one example is suggested inferior to thebroncho-aortic constriction (27.5 cm from the incisor teeth), butsuperior to the diaphragmatic constriction at 40 cm from the incisorteeth. The device typically should not be placed in regions of theesophagus with pathological involvement of the esophagus.

FIGS. 51 a-51 e show the device in plan and sectional views andindicated generally at 1400, and includes a main device body 1401 and afoam or air-filled esophageal cuff 1402 with a separate inflation lumen1404 for inflation and deflation as shown in FIGS. 51 b-51 d. FIG. 51 bshows the cuff 1402 in deflated position and FIG. 51 d shows the cuffinflated. Air channels 1405 connect the inflation lumen and the cuff asshown in FIGS. 51 b and 51 d. The section view in FIG. 51 b shows thetermination of the inflation lumen.

The tip of the device is shown positioned in the stomach, which is shownschematically in FIG. 51 a. FIG. 51 c is a cross-section taken alongline 51 c-51 c of FIG. 51 a. FIG. 51 d is a cross-section taken alongline 51 d-51 d of FIG. 51 a. FIG. 51 e is a cross-section taken alongline 51 e-51 e of FIG. 51 a. In these cross-sections, the various lumensare shown, including the main lumen 1406, the sump lumen 1408, theinflation lumen used for inflating the cuff, and any suction lumens 1410that are used for suction above the LES. The sump lumen 1408 isconnected to a sump port 1412 (FIG. 51 a) at the end of the device 1400.Drainage holes 1414 positioned in this example above the cuff 1402 allowsecretions to pass into the device. These drainage holes could be formedas suction holes such as in the example device described relative toFIG. 52 and connected to any suction lumens. Suction holes 1416 arepositioned below the cuff 1402 and connect to the suction lumens 1410 topermit emesis and reflux to be suctioned. The drainage holes could alsoconnect to the suction lumen 1410 as noted before. In a non-limitingexample, the drainage holes and suction holes include one-way valves toallow emesis to enter, but not return.

This device typically forms as a nasogastric or orogastric tube with aSalem sump port 1412 and an additional port 1404 a for air entry andexit to and from the esophageal cuff, allowing a high volume and lowpressure cuff 1402 as illustrated and supplied by the inflation lumen1404. The device can come in variable sizes and lengths depending onpatient needs and requirements and typically a standard size for usedepending on patients. The device can be used for gastric enteralfeedings or gastric decompression resulting from the use of the Salemsump port 1412. The device typically includes radio-opaque markings 1420throughout the length of the tube as illustrated for measurement andplacement. Measured markings 1421 as indicia can be positioned in oneexample along the length of the tube together with a color changingmaterial or pit sensitive material and at the bulb/cuff for measuringemesis, etc.

The cuff 1402 that is shown in its inflated position in FIG. 51 a ishigh volume and low pressure and can be inflated with air. It could befoam filled or a combination of both air and foam. Inflation anddeflation is through the leur lock port 1404 a that includes thepressure inflation balloon 1422 adjacent thereto. The inflation balloon1422 allows for a tactile cuff and a gross pressure check such asthrough a manometer 1424 attached thereto. The leur lock port 1404 aattaches in one example to a manometer for actual cuff pressuremeasurement. The cuff 1402 easily collapses for emergency removal orself-extubation without causing damage to surrounding structures of theesophagus, hypopharynx, pharynx, and oral cavity. The cuff is keptinflated below the capillary pressure of the esophageal wall to preventischemia that is typically about 7-8 centimeters (cm) water. Asindicated before, there are radio-opaque markings 1420 to aid in deviceplacement confirmation. The cuff can be radio-opaque to aid itsplacement. The upper portion of the esophageal cuff is typically mildlyconcave to promote secretion to flow towards openings as drainage holes1414 (or suction holes if formed as such) in the device in this example.An upward force, such as emesis or vomit on the lower portion of thecuff, expands the cuff outwards towards the esophageal wall to controlgastric contents from entering the hypopharynx. The inflation/deflationport 1404 a can be a different color than the openings for the sumplumen, the suction lumen and the main lumen. The inflation/deflationport 1404 a in one example is fitted with the standard leur lock cap andthe inflation/deflation port can be labelled with the term “esophagealcuff” to aid practitioners or identifying.

The NG/OG device is typically inserted through the nasal cavity orthrough the oral cavity and enters into the stomach. Measurements can bemade from the lips or nares to the TMJ (temporomandibular joint) and toabout four-finger breadths to sub-xyphoid. When the esophageal cuff 1402is deflated, a water-soluble lubricant can be applied to the end of thedevice to aid insertion. This NG/OG device is inserted in a mannersimilar to an OGT (orogastric tube) or NGT (nasal gastric tube) (NG/OGtube) with the clinician or nurse using the placement radio-opaquemarkings 1420 to position the device over the lungs and stomach. Once itis in position, it is possible to use auscultate placement by listeningto sounds and using an air bolus into the tube and attempt to aspirategastric contents from the tube. The tube is secured and its placementconfirmed by x-ray (using the radio-opaque markings 1420 for help) withthe preferred location inferior to the broncho-aortic constriction whilesuperior to the diaphragmatic constriction. The cuff 1402 is inflatedthrough the inflation lumen 1404 and the cuff pressure typicallymeasured with the manometer 1424. The main lumen 1406 as part of thedevice body 1401 will have low continuous or intermittent suction andmay also be used to administer external feedings.

The device 1400 is advantageous for use such as with the neurologicallyimpaired who are at risk for aspiration of gastric contents, includingthose suffering from a cerebrovascular accident that could be ischemic,thrombotic or hemorrhagic. The device can be advantageously used fornon-traumatic brain injury including encephalopathy or intracranialtumor/mass. The device can also be advantageously used when there istraumatic brain injury and general anesthesia, including intra-operativeor post-operative, for example, when the patient is neurologicallyimpaired and may not be able to protect their airways. The device isalso advantageously used with neurological disorders includingParkinson's Disease, amyotrophic lateral sclerosis and bulbarimpairment, myasthenia gravis, and multiple sclerosis. The device isadvantageously used with compromised consciousness such as throughalcohol intoxication, drug overdose and psychiatric disorders.Indications for use also include gastric decompression because of theuse of the sump port and gastric enteral feedings. There are somecontraindications for use of the device, including esophagealdisruption, esophageal stricture, esophagectomy, esophageal varices,connective tissue disease involving the integrity of the esophagus andcancer of the esophagus.

In accordance with a non-limiting example, the involuntary Reflex CoughTest (iRCT) is used to evaluate the impairment and/or recovery of airwayprotection. Cuff pressure can also be measured by the manometer 1424. Anadvantageous pressure for the cuff 1402 is below the esophageal wallcapillary pressure. The use of the involuntary reflex cough test isadvantageous for people who are neurologically impaired to check to seeif they can protect their airway. In this particular device example,pressure sensing is used in conjunction with the device. EMGdetermination can also be used, as well as pH sensing. Any transceiverinputs for pressure, pH or EMG could input directly into the handhelddevice. For example, the device could carry pressure sensors as pressuretransducers 1430 at various locations on the device to measure pressurewhen the device is inserted within the esophagus. The transducers 1430could have transducer leads 1432 that extend through the sump lumen 1408or be embedded in a wall of the main tube or one of the other lumens.One pressure sensor or transducer 1430 could be in the stomach (such asat the sump lumen), another at the LES, another at mid-esophageal and/oranother at the superior esophageal location. It is possible to use anair charged catheter as a pressure sensor with a separate lumen fordetermining pressure in the stomach, which can be used to determineintra-abdominal pressure. An air charged catheter would require somecalibration. Other sensors as non-limiting examples could use fiberoptic or other circuit means. The intra-abdominal pressure can bemeasured but also intra-thoracic pressure. Reflux can be measured byhaving pH sensors 1434 as inputs along the side with leads alsoextending through the sump lumen in this example. The handheld devicecan connect by wired connection or wireless connection to the variouspressure, pH and EMG sensors, probes, pads, transducers, etc. It shouldalso be understood that the catheter can be coated with a color changingmaterial, such as for indicating the extent of acid reflux or emesis.

FIG. 51 b shows the main device body in an area around the cuff 1402with the cuff in a deflated position. FIG. 51 c shows the differentlumens that extend through the device to the cuff area which is shown atFIG. 51 d. The lower portion of the device is shown in FIG. 51 e showingthe main lumen and the sump lumen.

FIGS. 52 a-52 f disclose an NG/OG device 1400 similar to that shown inFIGS. 51 a-51 e with similar components that are common between bothdevices having common reference numerals. In this particular example,however, the device includes a nebulizer lumen 1450 that is extralumenalto the main device body 1401 and provides a nebulizer function using aseparate nebulizer port 1452 from the main lumen. This nebulizer port1452 connects to an oxygen or air source for delivering medication suchas for the involuntary reflex cough test at the esopheryngeal area forinhalation into the pulmonary tree or medicine for treating a patient.As illustrated, the nebulizer lumen 1450 terminates at a nebulizerstructure or nebulizer/medication delivery mechanism having a built-inventuri 1454 to allow delivery of medication for the iRCT around aportion or all the main device body 1401 forming the tube.

FIG. 52 b shows a cross-section taken along line 52 b-52 b and showingthe venturi of the nebulizer and the main lumen 1406,deflation/inflation lumen 1404, suction lumen 1410, and sump lumen 1408that are similar as with the embodiment shown in FIGS. 51 a-51 e. Thetwo suction lumens 1410 could merge near the proximal portion of themain body or be separate and provide either common suction at the sametime above and below the cuff or individually controlled suction. Thesuction holes or ports as noted before include one-way valves to allowfluid into the suction lumen 1410, but not out. The valves could beformed as cut flaps that extend inward, but not outward to allowingress, but not egress. This is advantageous such as when emesisextends upward around the tube from the stomach and can pass into thetube to be suctioned, but not passed back out. Also, secretions, if theyget past the cuff, will be suctioned by the suction ports that arelocated above the cuff as illustrated.

The pressure transducers 1430 are located at various points such as atthe distal tip at the sump to measure intra-abdominal pressure. Apressure transducer 1430 can be located below the cuff 1430 and abovethe cuff 1402 with leads extending through the sump lumen 1408 andconnected to the handheld device. A pressure transducer 1430 in oneexample is located at the sump lumen as shown in FIG. 52 f. As notedbefore, it is also possible to include pH sensors 1434 on the devicethat include leads extending through the sump lumen 1408, allowing pH tobe measured to detect when emesis is rising from the stomach. The pHsensors 1434 could be located at different locations such as below thecuff and above the cuff and even farther up along the main device body1401. The coating on the device could indicate pH.

This NG/OG device as illustrated in FIGS. 52 a-52 f is a multi-purposeNG/OG device that can be used in a variety of patients who are at riskfor aspiration of gastric contents, elevated intra-abdominal and/orintra-esophageal pressures, and/or abnormal airway protection. Thedevice is not limited to the illustrated embodiments, but can beconfigured with all or any variation in combination of differentcomponents to fit the needs of the patient.

The main lumen 1406 extends the entire length of the device and as notedbefore, the device has radio-opaque markings 1420 along its length, andalso measurement markings 1421 as indicia in one example along itslength. The entire cuff can be radio-opaque to enhance placement. Thisdevice 1400 permits gastric decompression and can be used with a lowcontinuous or a low intermittent suction to remove gastric contents,including liquids and gaseous materials. The device allows enteralfeeding that can be administered into the gastric cavity for nutritionalsupport. Any enteral medication administration allows medications to beadministered into the gastric cavity.

The sump port 1412 as noted before is intra-lumenal with its own sumplumen 1408 and is integrated the entire length of the device. The sumpport opens at the end of the device and when located within the stomach,as when the device is in operation, prevents adherence of the device tothe gastric wall and also vents gastric gaseous build-up.

The nebulizer venturi 1454 permits inhalation medication administration.The venturi 1454 is extralumenal and connects to a high-flow oxygen orair source in a non-limiting example. Nebulized medications aredelivered through the venturi 1454, typically at the level of the larynxand hypopharynx. The involuntary reflex cough test can therefore beadministered efficiently using the device as described.

The cuff or inflation lumen 1404 provides inflation for the esophagealcuff, which as an inflatable cuff is located at the mid-esophagussection and can be inflated and deflated via the leur lock tip balloon1422 that provides a “feel” for the practitioner to aid in pressuremeasurements. The pressure of the cuff 1402 can be checked using amanometer 1424, which attaches to the leur lock tip. Gross pressure canbe tested manually using the indicator balloon. The esophageal cuff 1402provides a barrier for any refluxed gastric material from entering theupper esophagus and airway. An unplanned dislodgement of the esophagealcuff does not cause injury because of the particular cuff structure as aflexible material and its configuration to collapse when necessary.Also, the amount of pressure is not excessive enough to harm theesophageal wall in most instances.

The esophageal suction ports 1416, which in this embodiment are bothabove and below the cuff, permits suction to occur and uses one-way portholes that are located above and below the esophageal cuff such thatemesis, reflux and other material can be sucked into the suction lumen1410 but not pass out. The suction ports 1416 open with theadministration of low pressure and intermittent suction. Low suction canbe applied to remove the refluxed gastric material in the loweresophagus below the esophageal cuff. The low suction can also be appliedto remove material such as, but not limited to, oral or nasalsecretions, medications and/or tube feeding material that is collectedin the esophagus above the esophageal cuff. For purposes ofidentification to the nurse or other practitioner, it can be labelled as“Intra-Esophageal Access: Do Not Instill.”

The sump lumen typically will carry transducer leads that extend in thelumen and out past the discharge end of the sump lumen 1408, but theleads could be embedded in the wall of the device. The handheld deviceor other processing device can connect wirelessly or by wired connectionto the transducer leads and monitor pressure within the upper esophagus,the lower esophagus, and within the gastric cavity. Sensors or probesfor pH 1434 can be included as noted before and have leads extendingthrough the sump lumen 1408 and out past the proximal end. The leadsextending out of the sump lumen for those sensors, transducers or probescan connect to a transceiver for wireless signal transmission to thehandheld unit (or wired connection) in one embodiment. Any pressuretransducer can send its signal not only into the handheld device, butalso into a monitoring system that includes alarms to notify the staffof any increased pressures above or below the esophageal cuff or withinthe gastric cavity. Sensors for pH can be configured to sound an alarmsuch as when emesis occurs.

Typically, the nebulizer venturi 1454 will be positioned at the level ofthe larynx between the nasal pharyngeal area/oral pharyngeal area andallow medication to be administered. The device can be used to measureboth intra-abdominal hypertension and reflux. The dimensions of thisdevice are typically not larger than a regular NG/OG tube and not largerthan 18 to about 20 French. The sump lumen is much smaller as comparedto the main tube, but in this example, large enough to accommodatevarious leads, which could extend through other lumens. The sump lumen,however, typically remains more clean.

The NG/OG antireflux/emesis device as described with reference to thepreceding description includes suction both above and below the LowerEsophageal Sphincter (LES) as explained above. With placement of the“umbrella” or esophageal cuff close to a predetermined level below theaortic esophageal indentation, the inflation with saline or air opens apredetermined cuff shape similar to an hourglass cut in half in onenon-limiting example. The bowl shape as identified above as an examplecollects swallowed secretions and allows passage through both directionsfor gases. The umbrella would open a limited amount under emesispressure, and a sensor could flag or alert a monitoring system,triggered by the umbrella or cuff opening while at the same time,automatic suctioning could occur above the LES from the port. The deviceis also a fully functioning feeding tube for food, liquids or medicineto the stomach and acts as a separate reverse channel, to allowsuctioning below the LES in the stomach, and the possibility forconstant low-pressure suctioning for reflux above the LES. In apreferred example, the device collapses with pulling even if it is notdeflated and pulled by a patient for safety. As noted before, xrays canbe used to aid placement of the device in the esophagus. This device canbe engineered as necessary for any severe neuro functions and risks forLES weakness or increased LER activity because of dysphagia or reflux,and protect general anesthesia patients after extubation. The device isuseful for iRCT testing and protects the patient from neutral createdanti-acid medicine stomach content reflux the might get past the ASICreceptors or RAR's (retinoic acid receptors).

The device as described has many different advantageous uses. The topportion of the device includes different ports and non-ports, alloperating together as an NG/OG tube for oral or nasal uses. This devicealso can test reflex cough and deliver micro-nebulized medicines, suchas disclosed in commonly assigned U.S. patent application Ser. No.11/608,316 filed Dec. 8, 2006; Ser. No. 11/550,125 filed Oct. 17, 2006;Ser. No. 12/643,251 filed Dec. 21, 2009; and Ser. No. 12/643,134 filedDec. 21, 2009, the disclosures which are hereby incorporated byreference in their entirety.

The nebulizer lumen 1450 in one example typically extends about half thelength of the tube, and in an example is flush with the side of thetube. In FIG. 52 a, the device is shown broken in sections for claritysince it is not necessary to show the entire length of the device whenonly major components are to be illustrated. Nebulized medication entersthrough one of the ports at the top section of the nebulizer lumen,which terminates at the venturi as illustrated. The medication does notpass into the main tube, but around it, for example, at the level of thelarynx in this example. For example, the venturi could be locatedbetween the nasal pharyngeal and oral pharyngeal and/or distal.Medication can be administered into that portion of the airway.

The suction lumen includes the one-way valves at the suction ports 1416.Suction can be activated as when emesis occurs and it is brought intothe lumen. The main lumen 1406 forming the main device body 1401provides for food and fluid to pass into the stomach while the otherlumens as illustrated provide specific functions and are typicallyintegrated with the main device body.

The esophageal cuff 1402 is located on the outside of the main tube andcan be inflated and deflated as noted before. The balloon 1422 islocated such that the practitioner can manually feel the pressure of theballoon to exert pressure on the cuff 1402. Manually manipulating theballoon can place pressure on the esophagus via the cuff, and thus, thepractitioner can use the feel of the balloon and cuff in thisnon-limiting example such that the cuff will not cause tissue ischemia.

Suction can occur above and below the esophageal sphincter and suctioncan occur above and also below the cuff. There are, in some of theseexamples, one-way valves above and below the cuff that allow emesis orother material to go from outside the device to inside the tube. Theseone-way valves can be passive and fluid can enter through the one-wayvalves and be pushed down into the stomach or suctioned up in anotherexample. The device is designed such that emesis cannot come up aroundthe tube. This is important when the patient is unconscious and tubefed, allowing protection of the airway for the patient and protectingthe patient from any lower esophageal reflux such as with involuntaryevents. If a patient inhales, the lower esophageal sphincter closes. Ifan involuntary event, such as an involuntary reflex cough occurs, and apatient has not inhaled, reflux can occur. This has been shown with adamaged or malfunctioning urethral sphincter or damaged ormalfunctioning lower esophageal sphincter.

Guardian reflexes are typically parasympathetic driven. Theparasympathetics are cranial and sacral and the sympathetics arecervical, thoracic and lumbar. When a patient inhales, the diaphragmdrops and activates the dorsal and causes the lower esophageal sphincter(LES) above the stomach to close. If an event occurs and the internalsphincter does not close, the external sphincter is left alone. This iswhen patients leaked and why they often have stress incontinence. Theinvoluntary cough happens in about 17 milliseconds and they are not ableto inhale. There is no parasympathetic to close the inner sphincter,evident in graphs discussed before. This can be explained because theinternal sphincter closes with inhalation. Between every cough, there isan inhalation and the diaphragm drops and the dorsal motor nucleus andpara-abductal communicate with the parasympathetics from the cranial andsacral distribution. The device as explained is advantageous becausewhen reflux occurs, and if there is an involuntary cough and reflux, theairway is protected, especially if the patient is unconscious.

When the patient aspirates, a practitioner typically may try toneutralize the stomach contents. The airway will not be able to protectitself because of the neutral pH, and the reflex cough will not activatebecause the acid receptors are not activated (because of the neutralizedstomach). This protective device, in accordance with a non-limitingexample, is advantageous to protect the patient.

Normally if the contents are acidic, even if a patient is unconsciousand the cough is operative, then the patient would cough material outand this material would not move into the lungs. If the stomach has beenneutralized, however, the contents of the stomach may go past the acidreceptors and vocal cords and there could be an aspiration syndrome.

In the past, NG/OG tubes were not used with a patient that could notprotect their airway. This protective NG/OG device as described,however, in accordance with a non-limiting example, is safely used witha patient that cannot protect their airway and especially useful whenadministering the iRCT in case reflex occurs. The device can be left ina patient for protection.

The sump port 1412 is integrated into the side of the main tube formingthe main device body and exits the base of the tube into the stomach.The sump port vents and prevents adherence of the tube to the wall ofthe stomach if suctioning occurs, preventing complete vacuum and evencollapse of the stomach. A pressure transducer is placed at the sumpport (FIG. 52 f) for pressure measurements. The various sensors,transducers and probes typically may have leads that extend through thesump lumen and extend outward to plug into the handheld device. Thepressure of the stomach can be checked to give a measurement forintra-abdominal pressure and aid in determining intra-abdominalcompartment syndrome resulting from excess pressure. This could be aresting pressure. It is preferred, of course, in these scenarios, thatpressure not extend above 12 centimeters of water, for example,indicative of intra-abdominal hypertension. Thus, the device asdescribed can be used not only to measure intra-abdominal hypertensionsyndrome, but also to measure reflex cough. Typically, the reflex coughis activated from the nebulizer venturi 1454 when the various leads 1432are plugged into the handheld device either by wired or wirelessconnection. This is as effective in some instances as measuringintra-abdominal pressure from the bladder, but there are someevaluations that occur to reflect that the pressure is sometimes higherfrom the stomach than from the bladder, which could be a reflection ofdevice position.

Typically, voluntary cough is higher from the stomach than from thebladder. During this process, there could be higher reference numbersfor normal between the bladder and the stomach. If there is a rise innormal pressures, then there is possible intra-abdominal hypertension.Typically, the bladder is 12 centimeters of water as a cut-off and thestomach could possibly be 20 centimeters of water, but this value is tobe determined with greater testing.

This device prevents reflux from hurting a patient. The pressuretransducers 1430 located at the stomach below the cuff and at a pointabove the cuff are advantageous. If there is pressure build-up below thecuff, it is because the patient typically has vomited and there is nowfluid rising and there is possibly esophageal stretch that is placingpressure on the esophagus. It is possible to have a continuous read-outat the handheld unit of the various pressures along the esophagus and inthe stomach. It is possible to place alarms on the device, which willactivate if there is abnormal high or low pressure. For example, anabnormal high pressure could trigger an alarm and a nurse could assessthe patient to see if the patient needs to be suctioned, and whethersuction needs to occur above or below the cuff. Also, the nurse coulddetermine if there are intra-abdominal high pressures. It should beunderstood that the main lumen can be used to feed and the differentfluid ports, transducers, sensors and other components as describedbefore are positioned around the main lumen based on the necessaryphysiology and function required for the device.

The esophageal cuff 1402 is an umbrella-type device such that pressureopens the cuff and blocks emesis. This could be dangerous to theesophagus if proper designs are not used for the cuff. The cuff, i.e.,“umbrella,” is designed to readily collapse. If the cuff opens becauseof emesis or reflux, the opening could trigger a transducer operativewith the cuff and activate an alarm. A pressure transducer could belocated at that cuff location. If pressure occurs at the cuff by openingthe cuff, it will set the alarm off. The cuff in one example could bedesigned as a static blocking mechanism, and thus, be a static cuff, andin other instances a dynamic cuff. The design is important to ensurethat the cuff is not rigid such that it would rupture the esophagus.

The cross-section views in FIGS. 52 a and 52 e show suction ports aboveand below the cuff (FIG. 52 d). Any deflate/inflate port for the cuffcould be just above the cuff with a pressure transducer above and belowthe cuff in a non-limiting example.

As is understood, the esophagus is a low-pressure system, and the cuffwill typically operate as a low-pressure system. Low intermittentpressure is about 80 millimeters of mercury, and low continuous pressureis below about 80 millimeters of mercury. The esophagus is much smallerand the suction will typically be reduced to ensure that there is noexcess pressure against the walls of the esophagus to cause damage. Thepressure transducers, if strategically placed depending on the type ofpatient, can aid this determination. Air charged catheter technology canbe used for pressure measurement where changes in physiological pressureare transmitted through a micro-volume of trapped air.

FIG. 53 shows a catheter 1500 as a device used in a method fordiagnosing reflux during an involuntary event such as the involuntaryreflex cough test. As illustrated, this catheter 1500 does not includeany cuff as in previous embodiments shown in FIGS. 51 a-51 e and 52 a-52g and includes a catheter body 1502 having a single lumen 1504 in thisexample with a T-DOC transducer 1506. It is formed as a small, semi-softcatheter. The adult size is about 6 French and the pediatric size isabout 1-2 French. Two pressure sensor areas 1510, 1512 are formed forsensing pressure, for example, by using pressure transducers that areplaced at the tip of the catheter and approximately 10-15 centimetersfrom the tip. Different types of sensors could be used and transducerleads 1516 could extend along the side or in the catheter to the end.The catheter could be an air charged catheter. In one example, thecatheter is coated with a pH sensitive material 1520 that will changecolor when exposed to a pH less than about 4.0, indicating reflux.Measurement markings 1522 can be inserted or printed throughout thelength of the catheter. In one example, the catheter is an air-charged(T-DOC) for pressure measurement, but other types of sensing mechanismssuch as pressure sensors could be used as understood by those skilled inthe art. Fiber optics could be used. The catheter is radio-opaque andincludes such markings 1524, if radiologic placement is required and itcan include in-patient and out-patient indications.

The catheter can operate as an NG/OG and is inserted orally or nasallyinto the esophagus and through the lower esophageal sphincter (LES) intothe proximal stomach. Placement is measured from the lips (oral) ornares (nasal) to the TMJ (temporomandibular joint) to about four-fingerbreadths sub-xyphoid for adults.

The first sensor 1510 is located in the proximal stomach and can measureintra-gastric/intra-abdominal pressure. The second sensor 1512 islocated approximately in the mid-to-lower esophagus and can measureintrathoracic pressure. A pressure grading can be over the LES. EMGinformation typically can be measured to simultaneously record changesin pressure and gradients. EMG can be measured from the paraspinals asdescribed before. EMG sensors could be located at selected locations onthe catheter for EMG measurement in some examples. The catheter caninclude color change indicia for the pH sensitive material to measurethe height of refluxed, acidic gastric contents. The catheter caninclude pH sensors.

The catheter 1500 has the potential to identify SUI, assess Neurologicalairway protection (represented as one summated value) and SUI, andadditionally assess bladder physiology and categorize any classificationwith a programmed algorithm in incontinent patients using this one smallcatheter with EMG measurement. Any inputs of different values can be tothe handheld device as described.

When a different type of the same sized air charged gastric catheter isinserted from above, i.e. P.O. or NG, the device will measureNeurological airway for protection and assess gastro esophageal refluxfrom the involuntary maneuver epoch using the iRCT. This gastriccatheter, which can also measure pressure below the LES, canpredetermine gastric baseline pH and baseline esophageal pH above theLES at standard acid reflux levels already used in other pH testing.From that set up, with any catheters plugged into the handheld device(or eventually wirelessly to a wireless processing device), when givenan iRCT, the handheld processing device will assess if reflux is presentduring the iRCT epoch, such as when it occurs during and/or after theepoch by pH change at these levels. Whether the patients are beingtreated with acid neutralizers or not, the determined baseline sets theability to asses pH change when and where in the esophagus it occurs.

This approach will assess the severity of reflux compared to theresponse of the iRCT and magnitude of the involuntary cough epoch.Depending on the acid reflux elevation compared to the iRCT epoch,without inhalation tonicity protection, it could be instrumental instratifying reflux severity and pivotal in directing treatment anddemonstrating, with repeat testing, the efficacy of the treatment given.This device and process can be used for adult, pediatrics and newbornpatients.

If gastro esophageal reflux occurs regularly, it is most likelysecondary to an event that is a non-voluntary event, for example, abelch or involuntary cough, thus occurring without inhalation tonicityprotection. The reflex acid stimulation to the lung could be from thedistal esophagus reflex and very slow causing delayed cough, possiblyinvoluntary coughs (possibly a vicious cycle) or irritable lungreactions causing inhalation and voluntary coughs. Regardless, theywould not be temporally correlated by cough and reflux. This is reportedin Chang, “An objective study of acid reflux and cough in children usingan ambulatory pHmetry-cough logger” published online on Jun. 1, 2010 atArch Dis Child. The cough sensor as described in Chang could notdistinguish the different types of cough.

A question arises if an iRCT epoch when measured is temporarily relatedto reflux from the stomach during the epoch. It does not matter if thereis a small distal esophageal reflux, which is supported by Irwin in theAbstract entitled, “The Cough Reflex and Its Relation toGastroesophageal Reflux,” Am J Med, March 2000, or a huge geyser airwaylaryngeal reflux that the ENT's describe as causing severe larynx damageover time because of acid burn. Both reflux events can hurt the lungsover time eventually.

Reflux should be diagnosed during the actual involuntary event whenthere is little or no inhalation tonicity protection. This will lead toappropriate treatment decisions to protect the lungs, i.e., acidsuppression versus Fundoplication. The catheter device as describedcould be used for airway neuro measurement and bladder physiology, aswell as mouth to stomach to prove reflux during an involuntary maneuver.In one example, this may require different types of catheters fordifferent setups that all use the one handheld device for processing.

It should be understood that in the embodiments described above, thecuff operates similar to an umbrella. When the force of emesis hits it,the cuff will expand evenly without tearing or hurting the esophagus.The cuff material is typically a soft material. It should also beunderstood that this is advantageous because stroke could cause loweresophageal weakness and involuntary cough will not allow a patient tohave inhalation protection in some instances. The cuff on the deviceprovides such protection. The NG/OG tube as described with the cuff actsas an esophageal reflux protection device to protect a patient from thereflux caused by any weakness of the lower esophageal sphincter fromboth involuntary cough or muscle weakness from neurological injury orsimilar problems. When involuntary cough occurs, the stomach typicallydoes not close down. The cough can cause reflux, which causes more coughas a vicious cycle. In some instances, it is possible have a Foleycatheter and the smaller catheter tube as shown in FIG. 53 and leave theFoley and pull the catheter after a cough is measured for reflux. It isalso possible that the Salem sump as described can be radio-opaque suchas with a coating or a strip itself. The sump port itself could beradio-opaque to indicate where the port extends down into the stomach,such as about 6 centimeters in one example. Capillary pressure of theesophageal cuff can be about 7 to about 8 centimeters of water as asafety factor. The tube feeding channel, such as the main tube, would bea separate channel from the suction channel to ensure that the food isnot mixed with any emesis.

The devices, catheter and functions as described above are advantageous.If there is an involuntary cough and reflux, a patient can be protectedeven if they are unconscious. For example, at times the stomach may beneutralized in a clinical setting and the protective device isadvantageous to protect a patient from regurgitating their own stomachcontents. Normally, when the stomach contents are acidic, and even if apatient is unconscious, if reflux occurs, a patient would normally coughit out and the reflux or emesis would not pass into the lungs. If thecontents are neutral, however, they could discharge past the acidreceptors and vocal cords, causing aspiration syndrome. The device andmethodology therefore would test and prevent reflux damage and protect apatient's airway. The device can both feed and protect the patient.

Another advantageous aspect is that it is possible to accomplishinvoluntary cough and measure stomach pressure or intra-abdominalpressure during involuntary cough with the device as described. Theinvoluntary maneuver as a diagnostic tool with the device can be used todiagnose reflux. When the device is pulled out of a patient, theconfiguration of the cuff allows the cuff to collapse.

The devices can be used to measure the cough epoch in conjunction withEMG measurements as noted in the flowcharts above. It is advantageous todiagnose the cough epoch and also diagnose severity of disease. Thedevices in conjunction with other measurements can be used to diagnoseseverity of reflux during the involuntary epoch and determine the bestcourse of treatment. For example, if surgery is required or pelvic floorexercises or other treatment required. It allows a neuro anatomicalfinding. The devices can be used to measure pressure such as theabdominal pressure and reflux at the same time not only during the timeof the reflux, but also determine the height of the reflux for severity.

It should be understood that a pH probe can be located in the stomach,one at the LES, one at the mid-esophageal region, and one at thesuperior esophageal region or any combination. pH sensors could beformed electrodes. The devices could have color changing indicia as acoating on all or part of the device to aid in measuring pH and reflux.The devices can include pH sensors and pressure sensors, for example, anair charged sensor. Fiber optics can be used as noted before. A devicecould be used to protect a patient's airway, feed the patient,administer medication, and vacuum or “suck up” contents and preventaspiration in the stomach and esophagus. The device operates as adiagnostic tool in another example. The EMC shows a duration of theepoch or event and can be measured. It is typically measured from theparaspinals in an example. The device is used to diagnose GERD andprevent reflux in a non-limiting example.

It should be understood that the involuntary maneuver as describedbefore can be used to test for damaged or malfunctioningabdominal-pelvic intrinsic sphincter. When either a physical or chemicalsubstance stimulates receptors in the laryngeal mucosa, cough mayresult. Whether the cough is an involuntary reflex or a volitionalresponse depends upon the quantity and type of stimulus. The laryngealexpiratory reflex (LER) is an involuntary, brainstem-mediated reflex.The vagus (X) nerve in one example mediates the afferent component ofthe LER, and the efferent component is conveyed via the vagus, phrenic,intercostal and abdominal nerves. The reflex cough test (RCT) is acranial nerve examination assessing both the afferent sensory andefferent motor limbs of the laryngeal expiratory reflex. It is believedthat the RCT is presently the only means to test the integrity of theLER.

The laryngeal receptors and afferent fibers of the internal branch ofthe superior laryngeal nerve are involved in the laryngeal expiratoryreflex. Irritant receptors and Aδ afferent fibers appear to mediatelaryngeal cough. The receptors of the laryngeal mucosa arewell-innervated and sensitive to chemical stimuli. Fibers of the middleramus of the internal branch of the superior laryngeal nerve (ibSLN)directly distribute to receptors in the central region of the vestibularaspect of the quadrangular membrane. The internal branch of the superiorlaryngeal nerve represents the afferent component of the laryngealexpiratory reflex (LER). A laryngeal evoked potential has been recordedfrom the ibSLN after inhalation of tartaric acid-induced cough (RCT).Bilateral anesthesia of the internal branch of the superior laryngealnerve abolished the tartaric acid-induced laryngeal expiratory reflex.

Central processes of the superior laryngeal nerve (SLN) have been tracedto clusters of neurons in the vicinity of the nucleus tractus solitarius(NTS, solitary nucleus). Although the internal morphology of the nucleustractus solitarius in humans has been described, the central connectionspertaining to the laryngeal expiratory reflex and voluntary cough havenot been demonstrated in humans. SLN afferents terminate in the dorsalrespiratory group (DRG). In cats, the respiratory related neurons arefound in the DRG in the region of the nucleus tractus solitarius, andthe ventral respiratory group (VRG) which is rostral and caudal to theobex and next to the nucleus ambiguus. The rostral VRG includesexpiratory related neurons of the Bötzinger complex, located at therostral end of the VRG. The Bötzinger complex is adjacent to theexpiratory-related neurons of the retrofacial nucleus. The neuronsproject bilaterally to the ventrolateral region of the nucleus tractussolitarius, ventral respiratory group, phrenic nucleus, and spinal cord.The expiratory related neurons of the Bötzinger complex may have a rolein integration of inhibitory influences from the laryngeal receptors andlong, monosynaptic descending fibers from the Bötzinger complex maydirectly inhibit the motoneurons in the phrenic nucleus. The projectionof this integrated information to the expiratory premotor neurons of thecaudal VRG suggests a role in shaping the firing patterns of caudal VRGoutput.

Interneurons associated with the brainstem reticular formation probablyconvey sensory information from the NTS to the nucleus ambiguus, phrenicnucleus, dorsal motor nucleus of X, and medial motor cell column of thethoracic spinal cord. Efferent fibers from these nuclei course in thevagus nerve, phrenic nerve, and intercostal nerves, respectively, andproduce the complex motor response described as cough.

Central Ascending Pathways.

Sensory information originating from the laryngeal mucosa also projectsto the cerebrum. Caudal and medial aspects of the nucleus tractussolitarius, including the retrofacial nucleus, projectmedullohypothalamic (solitarohypothalamic) fibers to the posterolateralhypothalamus, and also convey reciprocal connections with theparaventricular nucleus. In cats, the nucleus tractus solitariusprojects to the lateral parabrachial nucleus and amygdala. Afferentinformation from the SLN may also reach the cerebral cortex in cats, andthe forebrain in rats. The medial solitary nucleus, a recipient of manychemoreceptor afferents in cats, has reciprocal connections with themesencephalic periaqueductal grey. In humans the nature of this pathwayand how it may relate to the initiation of a volitional cough isunclear.

Central Descending Pathways.

Although minor stimuli to the laryngeal mucosa may trigger the need forvoluntary cough, laryngeal stimuli or sensory innervation are notnecessary for the initiation of voluntary cough. Humans are capable ofvolitionally initiating or suppressing cough. Studies have reporteddisruption of the motor pattern involved in formulating a voluntarycough, a cortically mediated response in stroke subjects. Subjects, whohad an infarct in the dominant cerebral hemisphere, were significantlymore likely to demonstrate ‘cough apraxia,’ an inability to formulatethe motor patterns and/or sequence involved in the VC response. In thesesubjects, the LER, as elicited by brisk inhalation of nebulized tartaricacid, was normal.

Descending influences from areas of the frontoparietal cortex andsubcortical areas may modulate the laryngeal expiratory reflex ormediate the voluntary cough. Fibers from infralimbic and prelimbicregions of the medial frontal cortex terminate in the nucleus tractussolitarius in rats, bed nucleus of the stria terminalis, and amygdala incats. In cats, efferent fibers from the cortical nucleus of amygdaladescend to the hypothalamic ventromedial nucleus via the striaterminalis to the nucleus tractus solitarius and the nucleus ambiguus inthe medulla. This pathway is responsible for production of spasmodicexpiratory response like cough. Similar connections from the cortex,amygdala, and hypothalamus to the NTS have been reported in rats. Inrats, the prefrontal cortical fibers descend through the cerebralpeduncle and pyramidal tract to finally terminate in the dorsal NTS, aregion that receives substantial vagal and glossopharyngeal afferentinput. Descending fibers from subcortical areas such as the amygdala,bed nucleus of the stria terminalis, and the paraventricular, arcuateand posterolateral nuclei of the hypothalamus, course through themesencephalic and pontine tegmentum to terminate principally in theventral NTS. A case report indicated the inability to voluntarily coughfollowing a left cerebrovascular stroke. This report suggested apossible role of amygdalo-hypothalamo-reticular efferents in humans.Studies in cats indicate that neuronal functions associated withrespiration and respiratory-related activities can be suppressed bydescending influences from periaqueductal gray matter and nucleus raphemagnus. The function of these descending fibers, and how they mightrelate to a cortically mediated voluntary cough pathway in humansrequires further investigation.

Interneurons associated with the brainstem reticular formation mayconvey descending information from the cortical and subcortical regionsto the nucleus ambiguus, phrenic nucleus, and medial motor cell columnof the thoracic spinal cord. Efferent fibers from these nuclei course inthe vagus nerve, phrenic nerve, and intercostal nerves, respectively,and produce the complex motor response described as cough. In humans therole of descending fibers in the voluntary cough pathway in modulatingthe laryngeal expiratory reflex or mediating the voluntary cough awaitsfurther studies.

FIG. 53 b is a urodynamic tracing of a series of voluntary cough (VC) ina normal female subject with a urinary bladder filled with 200 ml ofsaline. There is no evidence of SUI, i.e., urine leakage, during theseries of VC or the five cough (C5) iRCT stimulus. With the iRCT theentire episode, which can have a duration of 14.8 seconds, during whichthere is no significant inhalation or lung inflation to activate US andLES tonicity. This subject is continent without the facilitatory effectof increased tonicity associated with lung inflation.

FIG. 53C is a urodynamic tracing of a series of VC in a female subjectwho has moderate/severe SUI. VC did not elicit urinary incontinencedespite the series of vigorous individual consecutive inhalation VCefforts. The iRCT caused immediate SUI with multiple leakages (redlines) during the 26 second involuntary event.

Abdominal and pelvic floor musculature (PFM) are co-activated duringvoluntary cough response (VCR) and involuntary reflex maneuvers tasks.The abdominal activation may displace the bladder neck, but this effectmay be different between the structurally and functionally differentmuscles of the abdominal wall (internal abdominal oblique (IAO),external abdominal oblique (OE), rectus abdominis (RA) and transversusabdominis (TA)). Furthermore, the timing of the abdominal and PFMcontraction in relation to the IAP can be important.

Although continence may be dependent on the net effect of each of thesefactors, no study has comprehensively investigated multiple elementssimultaneously or the potential of subtle differences in coordinativemechanisms.

Voluntary cough (VC) and the laryngeal expiratory reflex (LER) havedistinctly different neurophysiological and pharmacological mechanisms.Voluntary cough (VC) is classically defined as a cough that starts withan inspiration due to contraction of the diaphragm followed by briefglottal closure, contraction of the external abdominal oblique muscles,and subsequent glottal opening for the expiratory phase of the VC. VC isa cortically mediated response that requires appropriate sensory andmotor functions, praxis and cognition. As the lungs inflate duringinspiration there is a corresponding in the tonicity of both theurethral sphincter (US) and lower esophageal sphincter (LES). It is aplanned, learned motor event. Stroke subjects who had lesions involvingthe dominant cerebral hemisphere demonstrated cough apraxia—an inabilityto formulate the motor sequence associated with VC. Asking an obtunded,intubated or deaf patient to perform a VC poses obvious clinicaldifficulties. A videofluoroscopic study showed the depression of thediaphragm associated with inspiration following by an upwarddiaphragmatic displacement. VC did not displace (elevate) the diaphragmas much as reflex cough, which displaced the diaphragm to mid-sternallevels.

The laryngeal expiratory reflex (LER) is normally triggered when food,fluid or secretions enter the larynx during swallowing or inspiration.Reflex cough can be triggered by aspiration of food or fluid duringinspiration, acid reflux stimulation of laryngeal receptors orpost-nasal drip into the larynx or laryngeal inflammation or infection.

The LER is a brainstem-mediated reflex that initiates an immediateseries of expiratory coughs without an inspiratory phase. The LER is theinvoluntary reflex that neurologically protects the upper airway fromnoxious aspirants and, as such, it has a critical neurological function,which is unique to humans. An induced reflex cough test (iRCT), using anebulized 20% solution of a mild chemoirritant, has been used to elicita LER in subjects. The iRCT is characterized by a series of, at least,five expiratory reflex coughs (C5) with a 17 ms latency to the EAOmuscles. During the LER, contraction of the EAO muscles compress theabdominal viscera, which push against the relaxed diaphragm superiorlyfor the expiratory phase of VC and push inferiorly against the urinarybladder and rectum, with a concomitant increase in intra-abdominalpressure (IAP). Quantitative IAP measurements during VC and reflex coughhave been reported using a strain gauge pressure transurethral bladdercatheter and rectal catheter, and multi-channel urodynamic analysis ofpressure changes.

Since reflex cough is expiratory and is not preceded by diaphragmaticcontraction associated with inspiration, the iRCT indicates the nativetonicity and function of the US and LES, which is critical in thediagnosis of SUI and GERDS, respectively. Animal models cannotadequately study VC and the LER, since the animals are surgicallydecerebrated and intubated.

During coughing, the urethral sphincter (US) and lower esophagealsphincter (LES) are tonically closed to prevent urinary incontinence(UI) or gastroesophageal reflux. During VC, the inhalation precedes theexpiratory phase of VC and, like most cortically mediated motor events,causes a preparatory increase in US and LES muscle tone. Since the iRCTdoes not have an inspiratory phase, the US and LES muscle tone remainsin its native state of tonic closure. Patients who have stress UI (SUI)complain that they leak urine when they (reflex) cough, sneeze, exerciseor laugh. The patient often carefully performs VC and the patient'santicipation may trigger urethral reflexes (“guarding”) that mayincrease US tone, if physically and neurologically possible. The resultmay be favorable to the patient (no leak), but represents a suboptimaltest for SUI. If the patient demonstrates SUI during VC, they may havean intrinsic sphincter deficiency (ISD) involving the US, controlcircuits or structure.

A normal reflex cough, such as cough triggered by a brief aspiration ofa food particle, would normally trigger the LER and a concomitantincrease in IAP. If a patient has ISD involving the LES, then theincrease the IAP associated with a C5 series of LER coughs, which mayhave a duration of 15 seconds or more without an inspiration, may causereflux of gastric acid into the lower esophagus. The construct in thisscenario is that normal reflex coughing, perhaps compounded by a highBMI, may be the initial stimulus for subsequent coughing with acidreflux into the hypopharynx or larynx. If so, iRCT would be clinicallyuseful is testing the LES.

SUI and GERDS are two types of intrinsic sphincter deficiency (ISD). TheiRCT may be clinically useful in improved evaluation of LES function anda more realistic assessment of SUI.

FIG. 54 a is a diagram detailing what occurs during the LER (LaryngealExpiratory Reflex) and Intrinsic Sphincter Activity). This diagram showsa schematic of the LER neural circuits. FIG. 54 b illustrates VoluntaryCough (VC) pathways. There are some key points regarding VC,micturition, and the brainstem mediated LER. Voluntary Cough (VC) is acortically mediated, conditioned (learning) response. It is not areflex. It is a learned or developed neuromuscular sequence, which canbe disrupted or absent in some stroke patients. All VC events begin withan inspiration (inhalation), which has a premotor effect on the muscletone of the abdominal and pelvic sphincters. It can also be (and oftenis) attenuated by the subject during the urodynamic exam, since thesubject empirically knows the “level” of effort that would produce aleak. The VC cortically medicated micturition and LER are not the samecircuits and share only some motor nuclei, but probably not the sameterminations in these nuclei. VC does not use neurons in the nucleustractus solitarii (NTS), the principal sensory nucleus that mediates theLER patterned reflex pattern. The LER has a specific central patterngenerator in the medulla that is programmed (wired) to elicit a rapidneural protective reflex, which:

(1) clears the upper airway of potential aspirants; and

(2) closes abdominal and pelvic sphincters. This is a symmetrical andsynchronous reflex to the associated muscle. However, the smooth muscleof the internal urethral sphincter is quite slow compared to thestriated muscles of the EUS. This histological difference along withurinary bladder structural issues, patient demographics, and thepossibility of dyssynchronous firing of the bilateral LER circuits (auseful test in itself) may also be contributing factors. Nevertheless,the test appears to be a very reliable indicator as to the functionalintegrity of the CNS component of the LES circuit and, more on point,the integrity of the external urethral sphincter (EUS). If the EUSfails, SUI is almost immediate. If the EUS is intact and functioningcorrectly, SUI is an unlikely issue. This scenario relates to theevolution of upright posture, the displacement of the urinary bladderinto the pelvis in the late teens, and a social need for volitionalcontrol, except in situations where there is sphincter deficiency and anabrupt onset of intra-abdominal pressure).

The LER patterned reflex circuit is associated with a noxious stimulus(food or fluid aspiration) or a clinical test (such as the iRCT thatmimetics the effect of a noxious stimulus) that triggers supraglotticreceptors (superior to the vocal folds) in the larynx without apreceding inspiration. This last point plays a critical role in the LERcircuit and its role in continence.

During the LER cough epoch, it is not possible to inhale (inspire),which may be due to inhibition or blockage of the phrenic nucleus or aneffect on the inspiratory center in the brainstem, or both.Nevertheless, the subject cannot inhale during a properly administerediRCT. Without an inspiration (inhalation), the “presets” for theurethral sphincters appear to be quite different as shown on clinicaltrials.

The LER circuit involved a restricted region of the NTS and adjacentneuronal clusters. It has extensive reciprocal connections, whichinterconnect LER circuit neuronal groups with rapid descending pathwaysin the lateral reticulospinal tract (bulbospinal tract) and lateralvestibulospinal tract. These tracts have strong influences on autonomicnuclei in the spinal cord and motor nuclei to axial musculature.

FIG. 55 is an enlarged view of the epiglottis, vocal cords andvestibular region in which the C5 stimulus is received to receptors inthe larynx and the closure and opening of vocal folds are insynchronization with the LER cough epoch.

FIG. 56 is a diagram showing the diaphragm and the relaxation of thelower esophageal sphincter (LES) that occurs during the LER.

FIG. 57 is a diagram showing the bladder and other components andvarious nerves for purposes of illustration.

FIG. 58 shows a suggested sequence for the LER.

This application is related to copending patent applications entitled,“IMPROVED TECHNIQUES FOR EVALUATING URINARY STRESS INCONTINENCE AND USEOF INVOLUNTARY REFLEX COUGH AS A MEDICAL DIAGNOSTIC TOOL,” and“ORAL-ESOPHAGEAL-GASTRIC DEVICE TO DIAGNOSE REFLUX AND/OR EMESIS,” whichare filed on the same date and by the same assignee and inventors, thedisclosures which are hereby incorporated by reference.

Many modifications and other embodiments of the invention will come tothe mind of one skilled in the art having the benefit of the teachingspresented in the foregoing descriptions and the associated drawings.Therefore, it is understood that the invention is not to be limited tothe specific embodiments disclosed, and that modifications andembodiments are intended to be included within the scope of the appendedclaims.

That which is claimed is:
 1. An esophageal airway protection system,comprising: a nasogastric/orogastric (Ng/Og) device comprising: anelongate device body having a distal end for insertion into the stomachthrough the esophagus and a proximal end, and having a main lumenextending the length of the device; an inflatable esophageal cuffcarried by the device body mid-esophagus and an inflation lumen formedwithin the device body and connecting the inflatable esophageal cuffthrough which the esophageal cuff is inflated and deflated, wherein uponinflation of said esophageal cuff, emesis and/or reflux is blocked frompassing out of the stomach past the esophageal cuff positionedmid-esophagus to protect a patient's airway; a nebulizer lumen extendingalong the device body and comprising a port through which medication isdelivered for administrating an involuntary reflex cough test, whereinsaid esophageal cuff protects the airway during the involuntary reflexcough test; and a suction lumen formed within the device body andsuction ports communicating with the suction lumen and configured topermit suction from the esophagus above the lower esophageal sphincter(LES); at least one electromyogram (EMG) pad configured to be attachedto the lumbar region of a patient's back and obtain an EMG frominvoluntary cough activated paraspinal muscles; and a processing deviceconfigured to receive the EMG and process same to determine aphysiological abnormality.
 2. The esophageal airway protection systemaccording to claim 1, and further comprising a nebulizer venturiconnecting the nebulizer lumen and configured to deliver nebulizedmedication around the device body.
 3. The esophageal airway protectionsystem according to claim 1, and further comprising at least onepressure sensor located on the device body and configured to measureintra-abdominal pressure (IAP), wherein said processing device receivesthe IAP and correlates the IAP and EMG and involuntary reflex coughepoch.
 4. The esophageal airway protection system according to claim 3,wherein said at least one pressure sensor comprises a pressuretransducer and a transducer lead connecting the pressure transducer andextending to the proximal end.
 5. The esophageal airway protectionsystem according to claim 1, and further comprising at least one pHsensor carried by the device body, and said processing device receivespH measurements and processes same with EMG and IAP.
 6. The esophagealairway protection system according to claim 1, and further comprising asump port at the distal end and sump lumen formed the length of thedevice body and configured for venting gas and preventing adherence ofthe device against the gastric wall.